Design and preliminary results of a pilot randomized controlled trial on a 1:1:1 transfusion strategy: the trauma formula-driven versus laboratory-guided study.

J Trauma. 2011 Nov;71(5 Suppl 1):S418-26

Authors: Nascimento B, Rizoli S, Rubenfeld G, Lin Y, Callum J, Tien HC

Abstract

BACKGROUND: Retrospective reviews have recently shown an survival benefit for adopting a resuscitation strategy that transfuses plasma and platelets at a near 1:1 ratio with red blood cells (RBCs). However, a randomized controlled trial on the topic is lacking. We report on the design and preliminary results of our ongoing randomized control pilot trial (ClinicalTrial.gov NCT00945542).

METHODS: This is a 2-year feasibility randomized control trial at a single tertiary trauma center. Bleeding trauma patients were randomized to either a laboratory-driven or a formula-driven (1 plasma:1 platelet:1 RBC) transfusion protocols. Feasibility was assessed by analyzing for ability to enroll patients, appropriate activation of transfusion protocols, time to transfusion of each type of blood product, laboratory turnaround time, ratio of blood products transfused, and wastage of blood products.

RESULTS: From July 6, 2009, to May 31, 2010, n = 18 patients were randomized and included in the study. Issues that we noted were the need to do postrandomization exclusions, the need to have rapid and accurate predictors of massive bleeding to enroll patients quickly, and the need to have waived consent for study participation. As well, we noted that the logistics of administering 1:1:1 were formidable and required rapid access to thawed plasma. Similarly, challenges in the control arm of such a study included the turnaround time for obtaining laboratory results.

CONCLUSION: Despite major challenges, our initial experience suggests that with an organized system, it is possible to prospectively randomize massively bleeding trauma patients. The accomplishment of high ratios of plasma to RBCs is challenging with current thawing methods and unavailability of thawed plasma in Canada. Longer shelf-life for plasma and faster plasma thawing microwaves should overcome some of these obstacles. For a laboratory-guided transfusion protocol, massive transfusion protocols should be in place with faster turnaround time for coagulation tests. Finally, further research on predictors of massive transfusion is needed.

PMID: 22071998 [PubMed - indexed for MEDLINE]

On the road with injury prevention–an analysis of the efficacy of a mobile injury prevention exhibit.

J Trauma. 2011 Nov;71(5 Suppl 2):S505-10

Authors: Manno M, Rook A, Yano-Litwin A, Maranda L, Burr A, Hirsh M

Abstract

BACKGROUND: To assess the effectiveness of a mobile injury prevention vehicle (mobile safety street [MSS]) with a hands-on curriculum on instruction and retention of safety knowledge compared with traditional classroom safety curriculum among grade 5 elementary school children.

METHODS: Grade 5 students (n = 1,692) were asked to participate in the study as either the intervention group (MSS experience) or the comparison group (traditional classroom safety curriculum). Each student in the intervention group was asked to complete a series of three surveys. The first survey was given before the MSS visit (Fall 2009), the second immediately following the MSS visit (Fall 2009), and a third given 6 months after the MSS visit (Spring 2010) to measure knowledge retention. Students in the comparison group were asked to complete two surveys. The first survey was given at the same time as the intervention group (Fall 2009) and the second was given after the completion of the traditional classroom safety curriculum (Spring 2010).

RESULTS: Students scored on average 5.67 of 10 (5.56-5.80) before any safety instruction was given. After MSS instruction, mean scores showed a significant increase to 7.43 of 10 (7.16-7.71). Such increase was still measurable 6 months after the intervention 7.34 (7.04-7.66). The comparison group saw a significant increase in their mean scores 6.48 (6.10-6.89), but the increase was much smaller than the intervention group.

CONCLUSIONS: Community-based injury prevention programs are essential to reducing preventable injury and deaths from trauma. This study demonstrates that a hands-on program is more effective than traditional methods for providing safety knowledge.

PMID: 22072036 [PubMed - indexed for MEDLINE]

Effects of aggressive versus moderate glycemic control on clinical outcomes in diabetic coronary artery bypass graft patients.

Ann Surg. 2011 Sep;254(3):458-63; discussion 463-4

Authors: Lazar HL, McDonnell MM, Chipkin S, Fitzgerald C, Bliss C, Cabral H

Abstract

OBJECTIVE: This study sought to determine whether aggressive glycemic control (90-120 mg/dL) would result in more optimal clinical outcomes and less morbidity than moderate glycemic control (120-180 mg/dL) in diabetic patients undergoing coronary artery bypass graft (CABG) surgery.

SUMMARY OF BACKGROUND DATA: Maintaining serum glucose levels between 120 and 180 mg/dL with continuous insulin infusions decreases morbidity in diabetic patients undergoing CABG surgery. Studies in surgical patients requiring prolonged ventilation suggest that aggressive glycemic control (<120 mg/dL) may improve survival; however, its effect in diabetic CABG patients is unknown.

METHODS: Eighty-two diabetic patients undergoing CABG were prospectively randomized to aggressive glycemic control (90-120 mg/dL) or moderate glycemic control (120-180 mg/dL) using continuous intravenous insulin solutions (100 units regular insulin in 100 mL: normal saline) beginning at the induction of anesthesia and continuing for 18 hours after CABG. Primary end points were the incidence of major adverse events (major adverse events = 30-day mortality, myocardial infarction, neurologic events, deep sternal infections, and atrial fibrillation), the level of serum glucose, and the incidence of hypoglycemic events.

RESULTS: There were no differences in the incidence of major adverse events between the groups (17 moderate vs 15 aggressive; P = 0.91). Patients with aggressive control had a lower mean glucose at the end of 18 hours of insulin infusion (135 ± 12 mg/dL moderate vs 103 ± 17 mg/dL aggressive; P < 0.0001). Patients with aggressive control had a higher incidence of hypoglycemic events (4 vs 30; P < 0.0001).

CONCLUSIONS: In diabetic patients undergoing CABG surgery, aggressive glycemic control increases the incidence of hypoglycemic events and does not result in any significant improvement in clinical outcomes that can be achieved with moderate control. Clinical Trials.gov (ID #NCT00460499).

PMID: 21865944 [PubMed - indexed for MEDLINE]

Simulation-based mastery learning improves patient outcomes in laparoscopic inguinal hernia repair: a randomized controlled trial.

Ann Surg. 2011 Sep;254(3):502-9; discussion 509-11

Authors: Zendejas B, Cook DA, Bingener J, Huebner M, Dunn WF, Sarr MG, Farley DR

Abstract

OBJECTIVE: To evaluate a mastery learning, simulation-based curriculum for laparoscopic, totally extraperitoneal (TEP) inguinal hernia repair.

BACKGROUND: Clinically relevant benefits from improvements in operative performance, time, and errors after simulation-based training are not clearly established.

METHODS: After performing a baseline TEP in the OR, general surgery residents randomized to mastery learning (ML) or standard practice (SP) were reassessed during subsequent TEPs. The ML curriculum involved Web-based modules followed by training on a TEP simulator until expert performance was achieved. Operative time, performance, and patient outcomes adjusted for staff, resident participation, difficulty of repair, PGY-level, and patient comorbidities were compared between groups with mixed effects-ANOVA and generalized linear models.

RESULTS: Fifty residents (PGY1-5) performed 219 TEP repairs on 146 patients. Baseline operative time, performance, and demographics were similar between groups. To achieve mastery, ML-residents (n = 26) required a median of 16 (range 7-27) simulated repairs. After training, TEPs performed by ML-residents were faster than those by SP-residents, with time corrected for participation (mean ± SD, 34 ± 8 minutes vs. 48 ± 14 minutes; difference -13; 95%CI, -18 to -8; P < 0.001). Operative performance scores (GOALS, scale 6-30) were better for ML residents (21.9 ± 2.8 vs. 18.3 ± 3.8; P = 0.001). Intraoperative complications (peritoneal tear, procedure conversion), postoperative complications (urinary retention, seroma), and need for overnight stay were less likely in the ML group (adjusted odds ratios 0.14, 0.04, and 0, respectively; all P < 0.05).

CONCLUSIONS: A simulation-based ML curriculum decreased operative time, improved trainee performance, and decreased intra- and postoperative complications and overnight stays after laparoscopic TEP inguinal hernia repair. ClinicalTrials.gov Identifier: NCT01085500.

PMID: 21865947 [PubMed - indexed for MEDLINE]

Postinjury resuscitation with human polymerized hemoglobin prolongs early survival: a post hoc analysis.

J Trauma. 2011 May;70(5 Suppl):S34-7

Authors: Bernard AC, Moore EE, Moore FA, Hides GA, Guthrie BJ, Omert LA, Gould SA, Rodman GH,

PMID: 21841568 [PubMed - indexed for MEDLINE]

Brief violence interventions with community case management services are effective for high-risk trauma patients.

J Trauma. 2011 Jul;71(1):228-36; discussion 236-7

Authors: Aboutanos MB, Jordan A, Cohen R, Foster RL, Goodman K, Halfond RW, Poindexter R, Charles R, Smith SC, Wolfe LG, Hogue B, Ivatury RR

Abstract

BACKGROUND: Currently there are few data that brief violence intervention (BVI) and community case management services (CCMS) are effective for trauma patients admitted for interpersonal violence in terms of recidivism, service utilization, or alcohol abuse. The objective of this study is to assess outcomes for a cohort of young trauma patients in a prospective, randomized trial comparing BVI with BVI + CCMS.

METHODS: Intentionally injured patients, aged 10 years to 24 years, admitted to a Level I trauma center were randomized to receive a brief in-hospital psychoeducational violence intervention alone (Group I) or in combination with a 6 months wraparound CCMS (Group II) that included vocational, employment, educational, housing, mental health, and recreational assistance. Recidivism, alcohol use, and hospital and community service utilization were assessed at 6 weeks (6W) and 6 months (6M).

RESULTS: Seventy-five of 376 eligible injured patients were randomized into Group I and II. The two groups had similar demographics, injuries, and clinical outcomes. After discharge, percent clinic visits maintained was 57% in both the groups. Group II showed better hospital service utilization, CMS, and risk factor reduction at 6W and 6M. One patient in each group sustained a reinjury at 6M.

CONCLUSIONS: In-hospital BVI with community wraparound case management interventions can improve hospital and community service utilization both short- and long-term for high-risk injured patients. Longer follow-up is needed to show sustained reduction.

PMID: 21818029 [PubMed - indexed for MEDLINE]

Virtual reality pain control during burn wound debridement of combat-related burn injuries using robot-like arm mounted VR goggles.

J Trauma. 2011 Jul;71(1 Suppl):S125-30

Authors: Maani CV, Hoffman HG, Morrow M, Maiers A, Gaylord K, McGhee LL, DeSocio PA

Abstract

BACKGROUND: This is the first controlled study to explore whether adjunctive immersive virtual reality (VR) can reduce excessive pain of soldiers with combat-related burn injuries during wound debridement.

METHODS: Patients were US soldiers burned in combat attacks involving explosive devices in Iraq or Afghanistan. During the same wound care session using a within-subject experimental design, 12 patients received half of their severe burn wound cleaning procedure (~6 minutes) with standard of care pharmacologies and half while in VR (treatment order randomized). Three 0 to 10 Graphic Rating Scale pain scores for each of the treatment conditions served as the primary variables.

RESULTS: Patients reported significantly less pain when distracted with VR. “Worst pain” (pain intensity) dropped from 6.25 of 10 to 4.50 of 10. “Pain unpleasantness” ratings dropped from “moderate” (6.25 of 10) to “mild” (2.83 of 10). “Time spent thinking about pain” dropped from 76% during no VR to 22% during VR. Patients rated “no VR” as “no fun at all” (<1 of 10) and rated VR as “pretty fun” (7.5 of 10). Follow-up analyses showed VR was especially effective for the six patients who scored 7 of 10 or higher (severe to excruciating) on the “worst pain” (pain intensity) ratings.

CONCLUSIONS: These preliminary results provide the first evidence from a controlled study that adjunctive immersive VR reduced pain of patients with combat-related burn injuries during severe burn wound debridement. Pain reduction during VR was greatest in patients with the highest pain during no VR. These patients were the first to use a unique custom robot-like arm mounted VR goggle system.

PMID: 21795888 [PubMed - indexed for MEDLINE]

Postoperative long-term evaluation of interposition reconstruction compared with Roux-en-Y after total gastrectomy in gastric cancer: prospective randomized controlled trial.

Am J Surg. 2011 Sep;202(3):247-53

Authors: Ishigami S, Natsugoe S, Hokita S, Aoki T, Kashiwagi H, Hirakawa K, Sawada T, Yamamura Y, Itoh S, Hirata K, Ohta K, Mafune K, Nakane Y, Kanda T, Furukawa H, Sasaki I, Kubota T, Kitajima M, Aikou T

Abstract

BACKGROUND: The postoperative clinical superiority of the interposition of jejunum reconstruction (INT) to Roux-en-Y reconstruction (RY) after total gastrectomy has not been clarified. Postoperative quality of life (QOL) was evaluated between the 2 methods by a multi-institutional prospective randomized trial.

METHODS: A total of 103 patients with gastric cancer were prospectively randomly divided into groups for RY (n = 51) or INT reconstruction (n = 52) after total gastrectomy. They were stratified by sex, age, institute, histology, and degree of lymph node dissection. Postoperatively, body mass index (BMI) and nutritional conditions were measured serially, and QOL and postoperative squalor scores were evaluated at 3, 12, and 60 months and compared between the 2 groups.

RESULTS: After removing patients who did not complete the follow-up survey or censured cases, 24 patients in the RY group and 18 patients in the INT group were clinically available and their postoperative status was assessed. QOL scores were increased and complication scores were improved in the postoperative periods (P < .01). Postoperative BMI significantly deteriorated compared with preoperative BMI in each group. The postoperative QOL and complication scores at 60 months after surgery were significantly better than those at 3 months after surgery in each group (P < .01). However, there was no significant difference of QOL scores and postoperative complication scores between the 2 reconstruction groups. The nutritional condition in the INT group was nearly the same as that in the RY group.

CONCLUSIONS: Although our patient sample was small and patients who did not complete the follow-up survey were present, we could not identify any clinical difference between INT and RY after total gastrectomy 60 months after surgery. The safer and simpler RY method may be a more suitable reconstruction method than INT after total gastrectomy.

PMID: 21871978 [PubMed - indexed for MEDLINE]

Postoperative long-term evaluation of interposition reconstruction compared with Roux-en-Y after total gastrectomy in gastric cancer: prospective randomized controlled trial.

Am J Surg. 2011 Sep;202(3):247-53

Authors: Ishigami S, Natsugoe S, Hokita S, Aoki T, Kashiwagi H, Hirakawa K, Sawada T, Yamamura Y, Itoh S, Hirata K, Ohta K, Mafune K, Nakane Y, Kanda T, Furukawa H, Sasaki I, Kubota T, Kitajima M, Aikou T

Abstract

BACKGROUND: The postoperative clinical superiority of the interposition of jejunum reconstruction (INT) to Roux-en-Y reconstruction (RY) after total gastrectomy has not been clarified. Postoperative quality of life (QOL) was evaluated between the 2 methods by a multi-institutional prospective randomized trial.

METHODS: A total of 103 patients with gastric cancer were prospectively randomly divided into groups for RY (n = 51) or INT reconstruction (n = 52) after total gastrectomy. They were stratified by sex, age, institute, histology, and degree of lymph node dissection. Postoperatively, body mass index (BMI) and nutritional conditions were measured serially, and QOL and postoperative squalor scores were evaluated at 3, 12, and 60 months and compared between the 2 groups.

RESULTS: After removing patients who did not complete the follow-up survey or censured cases, 24 patients in the RY group and 18 patients in the INT group were clinically available and their postoperative status was assessed. QOL scores were increased and complication scores were improved in the postoperative periods (P < .01). Postoperative BMI significantly deteriorated compared with preoperative BMI in each group. The postoperative QOL and complication scores at 60 months after surgery were significantly better than those at 3 months after surgery in each group (P < .01). However, there was no significant difference of QOL scores and postoperative complication scores between the 2 reconstruction groups. The nutritional condition in the INT group was nearly the same as that in the RY group.

CONCLUSIONS: Although our patient sample was small and patients who did not complete the follow-up survey were present, we could not identify any clinical difference between INT and RY after total gastrectomy 60 months after surgery. The safer and simpler RY method may be a more suitable reconstruction method than INT after total gastrectomy.

PMID: 21871978 [PubMed - indexed for MEDLINE]

Prospective randomized comparative study of single incision laparoscopic cholecystectomy versus conventional four-port laparoscopic cholecystectomy.

Am J Surg. 2011 Sep;202(3):254-8

Authors: Lai EC, Yang GP, Tang CN, Yih PC, Chan OC, Li MK

Abstract

BACKGROUND: This study aimed to compare the outcomes of single-incision laparoscopic cholecystectomy (SILC) versus conventional 4-port laparoscopic cholecystectomy (LC).

METHODS: From November 2009 to August 2010, 51 patients with symptomatic gallstone or gallbladder polyps were randomized to SILC (n = 24) or 4-port LC (n = 27).

RESULTS: Mean surgical time (43.5 vs 46.5 min), median blood loss (1 vs 1 mL) and mean hospital stay (1.5 vs 1.8 d) were similar for both the SILC and 4-port LC group. There were no open conversions and no major complications. The mean total wound length of the SILC group was significantly shorter (1.76 vs 2.25 cm). The median visual analogue pain score at 6 hours after surgery was similar (4.5 vs 4.0) but the SILC group had a significantly worse pain score on day 7 (1 vs 0). There was no difference in time to resume usual activity (mean, 5.6 vs 5.0 d). The median cosmetic score of SILC was significantly higher than at 3 months after surgery (7 vs 6).

CONCLUSIONS: SILC was feasible and safe for properly selected patients in experienced hands.

PMID: 21871979 [PubMed - indexed for MEDLINE]

Prospective randomized comparative study of single incision laparoscopic cholecystectomy versus conventional four-port laparoscopic cholecystectomy.

Am J Surg. 2011 Sep;202(3):254-8

Authors: Lai EC, Yang GP, Tang CN, Yih PC, Chan OC, Li MK

Abstract

BACKGROUND: This study aimed to compare the outcomes of single-incision laparoscopic cholecystectomy (SILC) versus conventional 4-port laparoscopic cholecystectomy (LC).

METHODS: From November 2009 to August 2010, 51 patients with symptomatic gallstone or gallbladder polyps were randomized to SILC (n = 24) or 4-port LC (n = 27).

RESULTS: Mean surgical time (43.5 vs 46.5 min), median blood loss (1 vs 1 mL) and mean hospital stay (1.5 vs 1.8 d) were similar for both the SILC and 4-port LC group. There were no open conversions and no major complications. The mean total wound length of the SILC group was significantly shorter (1.76 vs 2.25 cm). The median visual analogue pain score at 6 hours after surgery was similar (4.5 vs 4.0) but the SILC group had a significantly worse pain score on day 7 (1 vs 0). There was no difference in time to resume usual activity (mean, 5.6 vs 5.0 d). The median cosmetic score of SILC was significantly higher than at 3 months after surgery (7 vs 6).

CONCLUSIONS: SILC was feasible and safe for properly selected patients in experienced hands.

PMID: 21871979 [PubMed - indexed for MEDLINE]

Evaluation of morbidity and mortality after anastomotic leakage following elective colorectal surgery in patients treated with or without mechanical bowel preparation.

Am J Surg. 2011 Sep;202(3):321-4

Authors: van’t Sant HP, Weidema WF, Hop WC, Lange JF, Contant CM

Abstract

BACKGROUND: A previous multicenter randomized trial demonstrated that mechanical bowel preparation (MBP) does not guard against anastomotic leakage in elective colorectal surgery. The aim of this complementary study was to evaluate the effects of MBP on morbidity and mortality after anastomotic leakage in elective colorectal surgery.

METHODS: A subgroup analysis was performed of a randomized trial comparing the incidence of anastomotic leakage and septic complications with and without MBP in patients undergoing elective colorectal surgery.

RESULTS: Elective colorectal surgery was performed in 1,433 patients with primary anastomoses, of whom 63 patients developed anastomotic leakage. Twenty-eight patients (44%) received MBP and 35 patients (56%) did not. Mortality rate, initial need for surgical reintervention, and extent of bowel contamination did not differ between groups (29% vs 40%; P = .497, P = .667, and P = .998, respectively).

CONCLUSIONS: No benefit of MBP was found regarding morbidity and mortality after anastomotic leakage in elective colorectal surgery.

PMID: 21871987 [PubMed - indexed for MEDLINE]

Evaluation of morbidity and mortality after anastomotic leakage following elective colorectal surgery in patients treated with or without mechanical bowel preparation.

Am J Surg. 2011 Sep;202(3):321-4

Authors: van’t Sant HP, Weidema WF, Hop WC, Lange JF, Contant CM

Abstract

BACKGROUND: A previous multicenter randomized trial demonstrated that mechanical bowel preparation (MBP) does not guard against anastomotic leakage in elective colorectal surgery. The aim of this complementary study was to evaluate the effects of MBP on morbidity and mortality after anastomotic leakage in elective colorectal surgery.

METHODS: A subgroup analysis was performed of a randomized trial comparing the incidence of anastomotic leakage and septic complications with and without MBP in patients undergoing elective colorectal surgery.

RESULTS: Elective colorectal surgery was performed in 1,433 patients with primary anastomoses, of whom 63 patients developed anastomotic leakage. Twenty-eight patients (44%) received MBP and 35 patients (56%) did not. Mortality rate, initial need for surgical reintervention, and extent of bowel contamination did not differ between groups (29% vs 40%; P = .497, P = .667, and P = .998, respectively).

CONCLUSIONS: No benefit of MBP was found regarding morbidity and mortality after anastomotic leakage in elective colorectal surgery.

PMID: 21871987 [PubMed - indexed for MEDLINE]

A high admission syndecan-1 level, a marker of endothelial glycocalyx degradation, is associated with inflammation, protein C depletion, fibrinolysis, and increased mortality in trauma patients.

Ann Surg. 2011 Aug;254(2):194-200

Authors: Johansson PI, Stensballe J, Rasmussen LS, Ostrowski SR

Abstract

OBJECTIVE: To investigate the association between markers of acute endothelial glycocalyx degradation, inflammation, coagulopathy, and mortality after trauma.

BACKGROUND: Hyperinflammation and acute coagulopathy of trauma predict increased mortality. High catecholamine levels can directly damage the endothelium and may be associated with enhanced endothelial glycocalyx degradation, evidenced by high circulating syndecan-1.

METHODS: Prospective cohort study of trauma patients admitted to a Level 1 Trauma Centre in 2003 to 2005. Seventy-five patients were selected blindly post hoc from 3 predefined injury severity score (ISS) groups (<16, 16-27, >27). In all patients, we measured 17 markers of glycocalyx degradation, inflammation, tissue and endothelial damage, natural anticoagulation, and fibrinolysis (syndecan-1, IL-6, IL-10, histone-complexed DNA fragments, high-mobility group box 1 (HMGB1), thrombomodulin, von Willebrand factor, intercellular adhesion molecule-1, E-selectin, protein C, tissue factor pathway inhibitor (TFPI), antithrombin, D-dimer, tissue-type plasminogen activator (tPA), urokinase-type plasminogen activator (uPA), soluble uPA receptor, and plasminogen activator inhibitor-1), hematology, coagulation, catecholamines, and assessed 30-day mortality. Variables were compared in patients stratified according to syndecan-1 median.

RESULTS: Patients with high circulating syndecan-1 had higher catecholamines, IL-6, IL-10, histone-complexed DNA fragments, HMGB1, thrombomodulin, D-dimer, tPA, uPA (all P < 0.05), and 3-fold increased mortality (42% vs. 14%, P = 0.006) despite comparable ISS (P = 0.351). Only in patients with high glycocalyx degradation was higher ISS correlated with higher adrenaline, IL-6, histone-complexed DNA fragments, HMGB1, thrombomodulin, and APTT, lower protein C (all P < 0.05), unchanged TFPI and blunted D-dimer response (P < 0.001) because D-dimer was profoundly increased even at low ISS. After adjusting for age and ISS, syndecan-1 was an independent predictor of mortality (OR: 1.01 [95%CI, 1.00-1.02]; P = 0.043).

CONCLUSIONS: In trauma patients, high circulating syndecan-1, a marker of endothelial glycocalyx degradation, is associated with inflammation, coagulopathy and increased mortality.

PMID: 21772125 [PubMed - indexed for MEDLINE]

Hypotensive resuscitation strategy reduces transfusion requirements and severe postoperative coagulopathy in trauma patients with hemorrhagic shock: preliminary results of a randomized controlled trial.

J Trauma. 2011 Mar;70(3):652-63

Authors: Morrison CA, Carrick MM, Norman MA, Scott BG, Welsh FJ, Tsai P, Liscum KR, Wall MJ, Mattox KL

Abstract

BACKGROUND: Trauma is a leading cause of death worldwide and is thus a major public health concern. Previous studies have shown that limiting the amount of fluids given by following a strategy of permissive hypotension during the initial resuscitation period may improve trauma outcomes. This study examines the clinical outcomes from the first 90 patients enrolled in a prospective, randomized controlled trial of hypotensive resuscitation, with the primary aim of assessing the effects of a limited transfusion and intravenous (IV) fluid strategy on 30-day morbidity and mortality.

METHODS: Patients in hemorrhagic shock who required emergent surgery were randomized to one of the two arms of the study for intraoperative resuscitation. Those in the experimental (low mean arterial pressure [LMAP]) arm were managed with a hypotensive resuscitation strategy in which the target mean arterial pressure (MAP) was 50 mm Hg. Those in the control (high MAP [HMAP]) arm were managed with standard fluid resuscitation to a target MAP of 65 mm Hg. Patients were followed up for 30 days. Intraoperative fluid requirements, mortality, postoperative complications, and other clinical data were prospectively gathered and analyzed.

RESULTS: Patients in the LMAP group received a significantly less blood products and total i.v. fluids during intraoperative resuscitation than those in the HMAP group. They had significantly lower mortality in the early postoperative period and a nonsignificant trend for lower mortality at 30 days. Patients in the LMAP group were significantly less likely to develop immediate postoperative coagulopathy and less likely to die from postoperatively bleeding associated with coagulopathy. Among those who developed coagulopathy in both groups, patients in the LMAP group had significantly lower international normalized ratio than those in the HMAP group, indicating a less severe coagulopathy.

CONCLUSIONS: Hypotensive resuscitation is a safe strategy for use in the trauma population and results in a significant reduction in blood product transfusions and overall IV fluid administration. Specifically, resuscitating patients with the intent of maintaining a target minimum MAP of 50 mm Hg, rather than 65 mm Hg, significantly decreases postoperative coagulopathy and lowers the risk of early postoperative death and coagulopathy. These preliminary results provide convincing evidence that support the continued investigation and use of hypotensive resuscitation in the trauma setting.

PMID: 21610356 [PubMed - indexed for MEDLINE]

The role of preconditioning and N-acetylcysteine on oxidative stress resulting from tourniquet-induced ischemia-reperfusion in arthroscopic knee surgery.

J Trauma. 2011 Mar;70(3):717-23

Authors: Koca K, Yurttas Y, Cayci T, Bilgic S, Kaldirim U, Durusu M, Cekli Y, Ozkan H, Hanci V, Purtuloglu T, Akgul EO, Oguz E, Yildiz C, Basbozkurt M

Abstract

BACKGROUND: The aim of this study was to investigate the effects of ischemic preconditioning (IPC) and N-acetylcysteine (NAC) on oxidative stress resulting from tourniquet-induced ischemia-reperfusion (IR) period in arthroscopic knee surgery.

METHODS: Forty-five patients who had arthroscopic knee surgery for meniscal and chondral lesions and for pathologic medial plica were included in this study. They were assigned to the following treatment groups: control (group C; n=15), IPC (group P; n=15), and NAC (group N; n=15). Subjects in the control group underwent routine surgical procedures. Subjects in the preconditioning group were subjected to temporary ischemia, with tourniquet performed by three compression cycles of 5 minutes followed by 5 minutes of reperfusion just before the application of tourniquet inflation. Subjects in the NAC group received 10 mg/kg NAC dissolved in 100 mL 0.9% normal saline intravenously 30 minutes before tourniquet inflation. An hour before the tourniquet was applied (preischemia) and 2 hours after tourniquet was removed (reperfusion), blood samples (to test for metabolites) were obtained. Levels of malondialdehyde (MDA), superoxide dismutase (SOD), glutathione peroxidase (GSH-Px), total antioxidant capacity (TAC), and total oxidant status (TOS) were measured in all serum samples. Results were compared between preischemia and reperfusion in three groups.

RESULTS: MDA in the control group was found to be increased significantly compared with preischemia, whereas MDA in IPC and NAC groups did not change insignificantly. SOD and GSH activities in the control group were found to be increased significantly, whereas SOD and GSH activities in IPC and NAC groups did not change significantly after reperfusion. TAC in the control group was found to be decreased and TOS was found to be increased significantly, but TAC and TOS in IPC and NAC groups were not significantly different after reperfusion. Mean serum MDA, TOS, SOD, and GSH-Px levels were lower in group P than group C at reperfusion period (p<0.05). Mean serum SOD levels were lower in group P than group N at reperfusion period (p<0.05).

CONCLUSIONS: Tourniquet-induced IR period in routine arthroscopic knee surgery resulted in oxidative stress by increasing MDA, SOD, GSH-Px, TOS and decreasing TAC. NAC and IPC had protective effect on occurrence of oxidative stress resulting from IR period by preventing MDA, SOD, GSH-Px, TAC, and TOS changes in routine arthroscopic knee surgery.

PMID: 21610364 [PubMed - indexed for MEDLINE]

Wound morbidity in mini-invasive thyroidectomy.

Surg Endosc. 2011 Jan;25(1):62-7

Authors: Dionigi G, Boni L, Rovera F, Rausei S, Dionigi R

Abstract

BACKGROUND: The incidence of wound morbidity (WM) after conventional thyroidectomy (CT) is 2 to 7%. This study evaluated the rate of WM after video-assisted thyroidectomy (VAT), with emphasis on surgical-site infections (SSIs).

METHODS: A total of 112 patients were recruited for this prospective, randomized surveillance analysis. The eligibility criteria included nodule smaller than 30 mm, gland volume less than 30 ml, and no previous neck surgery or advanced cancer. The exclusion criteria specified coexistent infection, immunosuppressive treatment, and pathologies requiring antibiotic prophylaxis. The patients were randomized for VAT or CT. Neither antibiotic prophylaxis nor a drain was used. The patients were followed after surgery for WM.

RESULTS: Both groups consisted of 56 patients. The rate for WM was significantly lower in the VAT group (n = 1) than in the CT group (n = 8) (p < 0.05). The incidence of SSI was 5.3% after CT and 0% after VAT (p < 0.05), and the most common pathogenic organism was Staphylococcus aureus. All WMs became evident after patient discharge. Wound infection was associated with prolonged ambulatory dressings.

CONCLUSIONS: No previous studies have compared the rates for WM associated with endoscopic versus open surgery in the cervical area. Wound morbidity was significantly reduced after VAT relative to CT. The authors underscore the important effect of the minor surgical trauma associated with VAT on the development of SSIs.

PMID: 20526624 [PubMed - indexed for MEDLINE]

Comparison of the open tension-free mesh-plug, transabdominal preperitoneal (TAPP), and totally extraperitoneal (TEP) laparoscopic techniques for primary unilateral inguinal hernia repair: a prospective randomized controlled trial.

Surg Endosc. 2011 Jan;25(1):234-9

Authors: Gong K, Zhang N, Lu Y, Zhu B, Zhang Z, Du D, Zhao X, Jiang H

Abstract

BACKGROUND: The open tension-free mesh-plug hernia technique, transabdominal preperitoneal (TAPP) technique, and totally extraperitoneal (TEP) laparoscopic technique all are common surgical procedures for primary unilateral inguinal hernia repair. However, the choice of the right surgical procedure still is controversial in China. This study aimed to compare open tension-free hernioplasty with two laparoscopic hernia repairs.

METHODS: In this study, 164 male patients with primary unilateral inguinal hernia were randomized to undergo an open operation with mesh-plug and patch, TAPP, or TEP.

RESULTS: Completion of the study required 3 years, from February 2006 to February 2009. Of the 164 patients, 62 underwent open repair, 50 had TAPP, and 52 had TEP. The patients then were followed up for 15.6 ± 8.5 months. The average operating time for the open repair group was significantly shorter than for the other two groups (p < 0.001). The cost for the open repair group also was significantly less than for the other two groups (p < 0.001). By contrast, the pain scores in the open mesh group were significantly higher than in the other two groups (p < 0.001). The hospital stay and the recovery time both were significantly longer in open repair group than in the other two groups (p < 0.001). No major complications or recurrence was found in any of the groups.

CONCLUSIONS: The findings show that open tension-free mesh-plug hernia repair, TAPP, and TEP are safe and effective for patients with primary unilateral inguinal hernia. Both TAPP and TEP are superior to open repair in terms of less postoperative pain and faster recovery time. The authors therefore recommend laparoscopic repair techniques as the preferable choice of surgical procedure. However, they think open repair will remain a practical solution in China because of its lower cost, short learning period, and need for no special equipment.

PMID: 20552368 [PubMed - indexed for MEDLINE]

Low-volume bowel preparation is inferior to standard 4 1 polyethylene glycol.

Surg Endosc. 2011 Mar;25(3):897-901

Authors: Haapamäki MM, Lindström M, Sandzén B

Abstract

BACKGROUND: Four liters or more of orally taken polyethylene glycol solution (PEG) has proved to be an effective large-bowel cleansing method prior to colonoscopy. The problem has been the large volume of fluid and its taste, which is unacceptable to some examinees. We aimed to investigate the effectiveness of 2 l PEG combined with senna compared with 4 l PEG for bowel preparation.

METHODS: The design was a single-center, prospective, randomized, investigator-blinded study with parallel assignment, in the setting of the Endoscopy Unit of Umeå University Hospital. Outpatients (n = 490) scheduled for colonoscopy were enrolled. The standard-volume arm received 4 l PEG, and the low-volume arm received 36 mg senna glycosides in tablets and 2 l PEG. The cleansing result (primary endpoint) was assessed by the endoscopist using the Ottawa score. The patients rated the subjective grade of ease of taking the bowel preparation. Analysis was on an intention-to-treat basis.

RESULTS: There were significantly more cases with poor or inadequate bowel cleansing after the low-volume alternative with senna and 2 l PEG (22/203) compared with after 4 l PEG (8/196, p = 0.027). The low-volume alternative was better tolerated by the examinees: 119/231 rated the treatment as easy to take compared with 88/238 in the 4 l PEG arm (p = 0.001).

CONCLUSIONS: 4 l PEG treatment is better than 36 mg senna and 2 l PEG as routine colonic cleansing before colonoscopy because of fewer failures.

PMID: 20812020 [PubMed - indexed for MEDLINE]

Do soft skills predict surgical performance?: a single-center randomized controlled trial evaluating predictors of skill acquisition in virtual reality laparoscopy.

World J Surg. 2011 Mar;35(3):480-6

Authors: Maschuw K, Schlosser K, Kupietz E, Slater EP, Weyers P, Hassan I

Abstract

BACKGROUND: Virtual reality (VR) training in minimal invasive surgery (MIS) is feasible in surgical residency and beneficial for the performance of MIS by surgical trainees. Research on stress-coping of surgical trainees indicates the additional impact of soft skills on VR performance in the surgical curriculum. The aim of this study was to evaluate the impact of structured VR training and soft skills on VR performance of trainees.

METHOD: The study was designed as a single-center randomized controlled trial. Fifty first-year surgical residents with limited experience in MIS (“camera navigation” in laparoscopic cholecystectomy only) were randomized for either 3 months of VR training or no training. Basic VR performance and defined soft skills (self-efficacy, stress-coping, and motivation) were assessed prior to randomization using basic modules of the VR simulator LapSim(®) and standardized psychological questionnaires. Three months after randomization VR performance was reassessed. Outcome measurement was based on the results derived from the most complex of the basic VR modules (“diathermy cutting”) as the primary end point. A correlation analysis of the VR end-point performance and the psychological scores was done in both groups.

RESULTS: Structured VR training enhanced VR performance of surgical trainees. An additional correlation to high motivational states (P < 0.05) was found. Low levels of self-efficacy and negative stress-coping were related to poor VR performance in the untrained control group (P < 0.05). This correlation was absent in the trained intervention group (P > 0.05).

CONCLUSION: Low self-efficacy and negative stress-coping strategies seem to predict poor VR performance. However, structured training along with high motivational states is likely to balance out this impairment.

PMID: 21190109 [PubMed - indexed for MEDLINE]

Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping for great saphenous varicose veins.

Br J Surg. 2011 Aug;98(8):1079-87

Authors: Rasmussen LH, Lawaetz M, Bjoern L, Vennits B, Blemings A, Eklof B

Abstract

BACKGROUND: This randomized trial compared four treatments for varicose great saphenous veins (GSVs).

METHODS: Five hundred consecutive patients (580 legs) with GSV reflux were randomized to endovenous laser ablation (980 and 1470 nm, bare fibre), radiofrequency ablation, ultrasound-guided foam sclerotherapy or surgical stripping using tumescent local anaesthesia with light sedation. Miniphlebectomies were also performed. The patients were examined with duplex imaging before surgery, and after 3 days, 1 month and 1 year.

RESULTS: At 1 year, seven (5.8 per cent), six (4.8 per cent), 20 (16.3 per cent) and four (4.8 per cent) of the GSVs were patent and refluxing in the laser, radiofrequency, foam and stripping groups respectively (P < 0.001). One patient developed a pulmonary embolus after foam sclerotherapy and one a deep vein thrombosis after surgical stripping. No other major complications were recorded. The mean(s.d.) postintervention pain scores (scale 0-10) were 2.58(2.41), 1.21(1.72), 1.60(2.04) and 2.25(2.23) respectively (P < 0.001). The median (range) time to return to normal function was 2 (0-25), 1 (0-30), 1 (0-30) and 4 (0-30) days respectively (P < 0.001). The time off work, corrected for weekends, was 3.6 (0-46), 2.9 (0-14), 2.9 (0-33) and 4.3 (0-42) days respectively (P < 0.001). Disease-specific quality-of-life and Short Form 36 (SF-36(®)) scores had improved in all groups by 1-year follow-up. In the SF-36(®) domains bodily pain and physical functioning, the radiofrequency and foam groups performed better in the short term than the others.

CONCLUSION: All treatments were efficacious. The technical failure rate was highest after foam sclerotherapy, but both radiofrequency ablation and foam were associated with a faster recovery and less postoperative pain than endovenous laser ablation and stripping.

PMID: 21725957 [PubMed - indexed for MEDLINE]

Intraperitoneal local anesthetic improves recovery after colon resection: a double-blinded randomized controlled trial.

Ann Surg. 2011 Jul;254(1):28-38

Authors: Kahokehr A, Sammour T, Shoshtari KZ, Taylor M, Hill AG

Abstract

BACKGROUND: Two wounds are created after abdominal surgery. The surgical insult to the peritoneal cavity and viscera has not been emphasized as a target for interventions. In animal models vagotomy blunts the intraperitoneal response to induced inflammation. This is not feasible in humans. However a transient chemical afferentectomy after colectomy by using neuraxial blockade (epidural) and intraperitoneal blockade may be possible. We investigated the effects of intraoperative instillation and postoperative infusion of intraperitoneal local anesthetic (IPLA) on recovery parameters after colectomy, in the setting of an established enhanced recovery after surgery (ERAS) program.

METHODS: Double blinded, randomized, placebo controlled design. The study group (IPLA) received instillation of intraperitoneal ropivacaine (75 mg) before dissection and postoperative infusion of 0.2% solution at 4 mL/hour for 3 days continuously. The placebo group (NS) was treated as above with 0.9% saline solution. All patients were cared for under ERAS standardized perioperative care. Epidural infusion was stopped on day 2. Patients were discharged from day 3 onwards once criteria met. Perioperative data, surgical recovery score (SRS), complications, and length of stay were recorded. Systemic cytokines response, neuroendocrine parameters, pain measures and opioid use data were collected. Patients were followed up for 60 days.

RESULTS: Sixty patients were recruited. Patients were equivalently matched at baseline. There were no local anesthetic related adverse events. The complication rate, including anastomotic leak rate, was equivalent between groups. IPLA group had better SRS scores for the duration of intraperitoneal infusion. Pain and opioid use was reduced in the IPLA group. Systemic cytokine and cortisol response was diminished in the IPLA group. IPLA group had consistently higher systemic ropivacaine levels than placebo group.

CONCLUSION: Instillation and infusion of intraperitoneal ropivacaine after colectomy improves early surgical recovery. This was associated with a blunting of postsurgical systemic cytokines and cortisol. Patients also had significantly reduced pain and opioid use over and above the effect of an epidural infusion. Therefore a transient chemical afferentectomy with clinical benefit is possible with this method. A longer IPLA infusion duration needs to be studied. This study is registered at clinicaltrials.gov and carries the ID number NCT00722709.

PMID: 21670611 [PubMed - indexed for MEDLINE]

Alcohol-related brief interventions as a criterion for American College of Surgeons Level I Trauma Center verification: how best to train the interventionists?

J Trauma. 2011 Apr;70(4):931-8

Authors: London JA, Dunn CW, Utter GH

The American College of Surgeons Committee on Trauma recently required that Level I trauma centers have the capability to perform counseling in the form of brief interventions (BIs) for injured patients identified as problem drinkers. However, it is not yet known what type of training is optimal for trauma center personnel who will conduct these BIs.

PMID: 21610398 [PubMed - indexed for MEDLINE]

Biomechanical evaluation for mechanisms of periprosthetic femoral fractures.

J Trauma. 2011 Apr;70(4):E62-6

Authors: Rupprecht M, Sellenschloh K, Grossterlinden L, Püschel K, Morlock M, Amling M, Rueger JM, Lehmann W

There are a number of biomechanical tests for various treatment options of periprosthetic femoral fractures, but different loading modalities prelude their direct comparison. This study was designed to develop an experimental model of osteoporotic bone fractures near the femoral stem that is based on a simple testing protocol to increase the reproducibility. In addition, we wanted to clarify whether a femoral prosthetic stem reduces the femoral fracture strength.

PMID: 21613972 [PubMed - indexed for MEDLINE]

Early results from a randomized trial of saphenous surgery with or without subfascial endoscopic perforator surgery in patients with a venous ulcer.

Br J Surg. 2011 Apr;98(4):495-500

Authors: Nelzén O, Fransson I,

The aim was to clarify the role of incompetent perforators (IPs) in venous leg ulcers. This short-term report focused on safety, patient satisfaction and the fate of IPs after subfascial endoscopic perforator surgery (SEPS), or saphenous surgery alone.

PMID: 21656715 [PubMed - indexed for MEDLINE]

Long-term follow-up of patients with a painless inguinal hernia from a randomized clinical trial.

Br J Surg. 2011 Apr;98(4):596-9

Authors: Chung L, Norrie J, O’Dwyer PJ

Up to one-third of patients with an inguinal hernia have no symptoms from the hernia. The aim of this study was to determine the long-term outcome of patients with a painless inguinal hernia randomized to observation or operation.

PMID: 21656724 [PubMed - indexed for MEDLINE]

Total or posterior partial fundoplication in the treatment of GERD: results of a randomized trial after 2 decades of follow-up.

Ann Surg. 2011 May;253(5):875-8

Authors: Mardani J, Lundell L, Engström C

We lack long-term data (>10 years) on the efficacy of antireflux surgery when evaluated within the framework of randomized clinical trials Hereby we report the outcome of a randomized trial comparing open total (I) and a Toupet posterior partial fundoplication (II) performed between 1983 and 1991.

PMID: 21451393 [PubMed - in process]

Open versus minimally invasive esophagectomy: a single-center case controlled study.

Surg Endosc. 2010 Dec;24(12):3044-53

Authors: Schoppmann SF, Prager G, Langer FB, Riegler FM, Kabon B, Fleischmann E, Zacherl J

Recent advances in laparoscopic and thoracoscopic surgery have made it possible to perform esophagectomy using minimally invasive techniques. Although technically complex, recent case studies showed that minimally invasive approaches to esophagectomy are feasible and have the potential to improve mortality, hospital stay, and functional outcome.

PMID: 20464423 [PubMed - indexed for MEDLINE]

Prospective randomized clinical trial comparing lightweight mesh and heavyweight polypropylene mesh in endoscopic totally extraperitoneal groin hernia repair.

Surg Endosc. 2010 Dec;24(12):3073-9

Authors: Chowbey PK, Garg N, Sharma A, Khullar R, Soni V, Baijal M, Mittal T

The purported advantage of lightweight large-pore meshes is improved biocompatibility that translates into lesser postoperative pain and earlier rehabilitation. However, there are concerns of increased hernia recurrence rate. We undertook a prospective randomized clinical trial to compare early and late outcome measures with the use of a lightweight (Ultrapro) mesh and heavyweight (Prolene) mesh in endoscopic totally extraperitoneal (TEP) groin hernia repair.

PMID: 20490567 [PubMed - indexed for MEDLINE]

Laparoscopic versus open appendectomy in men: a prospective randomized trial.

Surg Endosc. 2010 Dec;24(12):2987-92

Authors: Tzovaras G, Baloyiannis I, Kouritas V, Symeonidis D, Spyridakis M, Poultsidi A, Tepetes K, Zacharoulis D

The role of laparoscopic treatment in acute appendicitis still is unclear. Although some evidence in the literature suggests diagnostic benefits from laparoscopy for young women with suspected acute appendicitis, there is scepticism about the utility of this approach for men. This study aimed to compare open and laparoscopic appendectomy performed for men with suspected acute appendicitis.

PMID: 20552369 [PubMed - indexed for MEDLINE]

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Conservative treatment of early breast cancer. Long-term results of 1232 cases treated with quadrantectomy, axillary dissection, and radiotherapy.

Ann Surg. 1990 Mar;211(3):250-9

Authors: Veronesi U, Salvadori B, Luini A, Banfi A, Zucali R, Del Vecchio M, Saccozzi R, Beretta E, Boracchi P, Farante G

One thousand two hundred and thirty-two women with invasive breast cancer lesions measuring less than 2 cm in diameter, clinically assessed as T1N0-1M0, were treated from 1970 to 1983 at the National Cancer Institute of Milan with quadrantectomy, axillary dissection, and radiotherapy (QUART). Pathologic evidence of lymph-nodes metastases was found in 32% of the patients. Overall survival at 5 and 10 years from surgery was 91% and 78%, respectively. The cumulative probability of survival tends to decrease with increasing tumor size: the 7-year survival rate was 84% in cases in which lesions measured from 1.6 to 2.0 cm, and 94% in cases in which the lesions were less than 0.5 cm. Tumor site in the treated breast did not affect distant outcome. No difference was found between the patients without node metastases and patients with one node involved, whereas the patients with more than one node showed a lower probability of survival. The survival curves of 352 cases treated inside a randomized trial and that of 880 cases routinely treated appear to be superimposable. Local recurrences and new primary ipsilateral tumors were, respectively, 35 (2.8%) and 19 (1.6%); 56 women with local recurrences or second tumors underwent second surgery (total mastectomy, 43; wide resection, 11). Five of them died from distant spread of breast cancer, while 49 are alive and well. In the contralateral breasts 45 carcinomas were recorded during the follow-up time. The results of the present analysis of a large number of T1 cases reconfirm the safety of integrated radiosurgical conservative treatments.

PMID: 2106841 [PubMed - indexed for MEDLINE]

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Distal splenorenal shunt versus endoscopic sclerotherapy in the prevention of variceal rebleeding. First stage of a randomized, controlled trial.

Ann Surg. 1990 Feb;211(2):178-86

Authors: Spina GP, Santambrogio R, Opocher E, Cosentino F, Zambelli A, Passoni GR, Cucchiaro G, Macrì M, Morandi E, Bruno S

In 1984 we started a prospective controlled trial comparing endoscopic sclerotherapy (ES) with the distal splenorenal shunt (DSRS) in the elective treatment of variceal hemorrhage in cirrhotic patients. The study population included 40 patients with cirrhosis and portal hypertension referred to our department from October 1984 to March 1988. These patients were drawn from a pool of 173 patients who underwent either elective surgery or endoscopic sclerotherapy during this time. Patients were assigned to one of the two groups according to a random-number table: 20 to DSRS and 20 to ES. During the postoperative period, no DSRS patient died, while one ES patient died of uncontrolled hemorrhage. One DSRS patient had mild recurrent variceal hemorrhage despite an angiographically patent DSRS. Four ES patients suffered at least one episode of gastrointestinal bleeding: two from varices and two from esophageal ulcerations. Five ES patients developed transitory dysphagia. Long-term follow-up was complete in all patients. Two-year survival rates for shunt (95%) and ES (90%) groups were similar. One DSRS patient rebled from duodenal ulcer, while three ES patients had recurrent bleeding from esophagogastric sources (two from varices and one from hypertensive gastropathy). One DSRS and two ES patients have evolved a mild chronic encephalopathy; four DSRS and two ES patients suffered at least one episode of acute encephalopathy. Two ES patients had esophageal stenoses, which were successfully dilated. Preliminary data from this trial seem to indicate that DSRS, in a subgroup of patients with good liver function and a correct portal-azygos disconnection, more effectively prevents variceal rebleeding than ES. However no significant difference in the survival of the two treatment groups was noted.

PMID: 2405792 [PubMed - indexed for MEDLINE]

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Gastric surgery for morbid obesity. The Adelaide Study.

Ann Surg. 1990 Apr;211(4):419-27

Authors: Hall JC, Watts JM, O’Brien PE, Dunstan RE, Walsh JF, Slavotinek AH, Elmslie RG

The efficacy of three gastric restriction operations were compared in a prospective randomized study of 310 morbidly obese subjects. The median patient age was 34 years (range, 18 to 62 years). They were predominantly female (13:1) and had a median pre-operative weight that was 198% of their ideal weight (range, 160% to 318%). There was an equitable dispersion of perceived risk factors between the groups under study and there were no deaths during the perioperative period. Compliance with follow-up at 3 years was 91%. When success was defined as a loss of more than 50% of excess weight or a current pregnancy, the success rates at 3 years were 17% for gastrogastrostomy, 48% for vertical gastroplasty, and 67% for Roux-en-Y gastric bypass (p less than 0.001). Although the gastric bypass operation took longer to perform, there were similar outcome patterns for the three groups during the postoperative period. We conclude that the Roux-en-Y gastric bypass is the preferred procedure for the surgical treatment of morbid obesity.

PMID: 2181950 [PubMed - indexed for MEDLINE]

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Antiplatelet treatment prolongs survival after carotid bifurcation endarterectomy. Analysis of the clinical series followed by a controlled trial.

Ann Surg. 1990 Mar;211(3):317-22

Authors: Kretschmer G, Pratschner T, Prager M, Wenzl E, Polterauer P, Schemper M, Ehringer H, Minar E

To examine the role of antiplatelet drugs in the secondary prevention of arteriosclerotic arterial disease following carotid endarterectomy, a clinical series (n = 252) was analyzed. Based on these results a prospective randomized trial was initiated, comparing the effect of antiplatelet drugs (acetyl-salicylic acid [ASA] 1000 mg/day) versus untreated controls. In both investigations patient survival was the primary end point. A cardiac risk (n = 91) implied a significant reduction in patient survival (p less than 0.019 Breslow, p less than 0.052 Mantel). Antiaggregating drugs prolonged survival in the collective series (p less than 0.0001 Breslow, p less than 0.0002 Mantel) and in the subgroup of patients with cardiac risk (p less than 0.014 Breslow, p less than 0.020 Mantel) as well. In the prospective trial 66 patients were recruited, receiving ASA (n = 32) versus no therapy (n = 34). During follow-up 15 patients died, 4 in the treatment, and 11 in the control group. Between both groups there was a significant difference in the probability of survival (p less than 0.021 Breslow, p less than 0.048 Mantel).

PMID: 2178566 [PubMed - indexed for MEDLINE]

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Survival following locoregional recurrence after breast conservation therapy for cancer.

Ann Surg. 1990 Aug;212(2):166-72

Authors: Stotter A, Atkinson EN, Fairston BA, McNeese M, Oswald MJ, Balch CM

We postulated that locoregional recurrence after limited surgery and radiotherapy for breast cancer might be associated with an additional survival hazard, similar to that of a second primary tumor with the same extent of local and regional disease. Using this hypothesis we examined the likely resultant effect on survival. Our calculations indicated that no statistically significant survival deficit due to such recurrence would be detectable until a randomized controlled trial comparing breast conservation with mastectomy had monitored more than 10,000 patients for more than 10 years. A simple mathematical model predicted 5-year survival rates in a cohort of patients treated with breast conservation of 75%, compared to 83% in those without locoregional recurrence. From the date of locoregional recurrence, a 61% 5-year survival rate was predicted, compared to 83% if no hazard was associated with locoregional recurrence. These predictions were compared with the actuarial survival rates of 499 patients with unilateral breast cancer, 49 of whom had developed locoregional recurrence. From the date of initial treatment, the 5-year survival rate of those whose disease recurred was 79%, compared to 88% for those without locoregional recurrence (p = 0.19). The actuarial 5-year survival rate from the date of locoregional recurrence was 63%. The similarity between the patient data and the predictions of the mathematical model indicates that locoregional failure after breast conservation therapy may result in reduced survival. The lack of a significant survival deficit in our cohort or in controlled trials comparing breast conservation therapy with mastectomy is compatible to the small size of the overall effect.

PMID: 2198001 [PubMed - indexed for MEDLINE]

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Superiority of closed suction drainage for pancreatic trauma. A randomized, prospective study.

Ann Surg. 1990 Jun;211(6):724-8; discussion 728-30

Authors: Fabian TC, Kudsk KA, Croce MA, Payne LW, Mangiante EC, Voeller GR, Britt LG

During a 42-month period, 65 patients sustaining pancreatic injuries were treated. They were randomized on alternate days (two separate trauma teams) to receive sump (S) or closed suction (CS) drainage. Twenty-eight patients were randomized to S and 37 to CS; there were six early deaths, which precluded drainage analysis, leaving 24 evaluable S patients and 35 CS patients. Penetrating wounds occurred in 71% and blunt in 29%. No significant differences appeared between the groups with respect to age, Penetrating Abdominal Trauma Index (PATI), Injury Severity Score (ISS), or grade of pancreatic injury. Twelve patients in each group required resection and drainage for grade III injuries, with the remaining patients receiving external drainage alone. Five of twenty-four S patients versus one of thirty-five CS patients developed intra-abdominal abscesses (p less than 0.04). We conclude that septic complications after pancreatic injury are significantly reduced by CS drainage. Bacterial contamination via sump catheters is a major source for intra-abdominal infections after pancreatic trauma.

PMID: 2192695 [PubMed - indexed for MEDLINE]

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Beneficial effect of enhanced macrophage function in the trauma patient.

Ann Surg. 1990 May;211(5):605-12; discussion 612-3

Authors: Browder W, Williams D, Pretus H, Olivero G, Enrichens F, Mao P, Franchello A

Host immunosuppression after trauma contributes to septic morbidity. The macrophage is a key element in the host immune response. This study evaluated glucan, a macrophage stimulant, in a prospective, randomized, double-blind study of 38 trauma patients undergoing surgery. Glucan (21 patients), 50 mg/m2, or placebo (17 patients) was given intravenously daily for 7 days. Delayed hypersensitivity skin testing was performed on days 1 and 7 after trauma. Serum interleukin-1 (IL-1) and tumor necrosis factor (TNF) were assayed after trauma. While the total mortality rate was significantly less in the glucan group (0% versus 29%) (p less than 0.05), the mortality rate from sepsis was not statistically different (0% versus 17.6%). Glucan therapy significantly decreased septic morbidity (9.5% versus 49%; p less than 0.05). Serum IL-1 had a greater increase in glucan patients on day 3 after trauma (143.4 +/- 19.3% versus 78.6 +/- 11.7%; p less than 0.05), but there was no difference thereafter. Serum TNF did not vary between groups. Early increase in IL-1 correlated with subsequent skin test conversion to positive. Neither serum IL-1 nor TNF was a reliable indicator of future sepsis. Further clinical trials are indicated to evaluate biologic response modifiers that activate macrophages in the trauma patient.

PMID: 2111126 [PubMed - indexed for MEDLINE]

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Efficacy of octreotide acetate in treatment of severe postgastrectomy dumping syndrome.

Ann Surg. 1990 Dec;212(6):678-87

Authors: Geer RJ, Richards WO, O’Dorisio TM, Woltering EO, Williams S, Rice D, Abumrad NN

The present study evaluates the acute and chronic use of a long-acting somatostatin analog, octreotide acetate, in the treatment of patients with severe postgastrectomy dumping syndrome. In the acute phase, 10 patients with severe dumping were studied over 2 consecutive days before and for 3 hours after the ingestion of a ‘dumping breakfast’ in a randomized double-blind fashion. On one day octreotide (100 micrograms) was given subcutaneously 30 minutes before the test meal and on the other day an equal volume of vehicle was injected. An additional group of six postgastrectomy patients without dumping were studied in a similar fashion and these acted as controls. During placebo treatment the test meal resulted in an immediate increase (p less than 0.01) in the pulse rate and in plasma levels of glucose, glucagon, pancreatic polypeptide, neurotensin, and insulin. Similar changes were seen in the control group with respect to placebo; however glucagon and neurotensin (p less than 0.05) did not show the same magnitude of increase as seen with placebo. Treatment with octreotide acetate prevented the development of both vasomotor and gastrointestinal symptoms and completely ablated all of the above responses in plasma peptides. These changes were associated with complete ablation of diarrhea (p less than 0.001). Pretreatment with octreotide acetate completely suppressed the rise in plasma insulin response to the meal and this ablated the late hypoglycemia of dumping. Treatment with octreotide acetate resulted in delayed gastric emptying and transit time (578 +/- 244 minutes) versus 76 +/- 23 minutes with placebo and 125 +/- 36 minutes in controls (p less than 0.05). Chronic daily treatment with octreotide acetate resulted in minimal side effects. These patients demonstrated a stable fasting plasma glucose, normal liver function tests, and an average weight gain of 11% during a 12-month period. In addition most patients were able to resume employment. The long-acting somatostatin analog, octreotide acetate, is highly effective in preventing the development of symptoms of severe dumping syndrome, both vasomotor and gastrointestinal.

PMID: 2256759 [PubMed - indexed for MEDLINE]

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Hepatic resection for disseminated germ cell carcinoma.

Ann Surg. 1990 Sep;212(3):290-3; discussion 293-4

Authors: Goulet RJ, Hardacre JM, Einhorn LH, Loehrer PJ, Jones JA, Donohue JP, Madura JA, Grosfeld JL

Improvements in operative technique and perioperative management have expanded the application of hepatic resection for metastatic cancer. Although a policy of aggressive surgical resection of residual pulmonary and retroperitoneal disease following chemotherapy and normalization of serum tumor markers has been adopted for disseminated germ cell carcinoma, resection of residual hepatic disease in these cases has not been addressed. This report concerns a series of prospectively randomized patients who received systemic cisplatin-based chemotherapy for testis cancer during the past 13 years. Twenty-eight patients underwent resection of residual hepatic disease after serologic remission. Most (23 of 28 patients) of these procedures were performed concomitantly with other cytoreductive procedures. There were no operative deaths, although 28% of the patients developed complications. The 2-year survival rate was 54%, with an average follow-up of 34 months. Patients were stratified into three groups based on the most aggressive histology noted in the resected specimen. Survival is predicted by this histologic classification system. Hepatic resection can be performed safely and is an important component in the treatment of disseminated testicular carcinoma.

PMID: 2168694 [PubMed - indexed for MEDLINE]

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Prehospital hypertonic saline/dextran infusion for post-traumatic hypotension. The U.S.A. Multicenter Trial.

Ann Surg. 1991 May;213(5):482-91

Authors: Mattox KL, Maningas PA, Moore EE, Mateer JR, Marx JA, Aprahamian C, Burch JM, Pepe PE

The safety and efficacy of 7.5% sodium chloride in 6% dextran 70 (HSD) in posttraumatic hypotension was evaluated in Houston, Denver, and Milwaukee. Multicentered, blinded, prospective randomized studies were developed comparing 250 mL of HSD versus 250 mL of normal crystalloid solution administered before routine prehospital and emergency center resuscitation. During a 13-month period, 422 patients were enrolled, 211 of whom subsequently underwent operative procedures. Three hundred fifty-nine patients met criteria for efficacy analysis, 51% of whom were in the HSD group. Seventy-two per cent of all patients were victims of penetrating trauma. The mean injury severity score (19), Trauma Score plus Injury Severity Score (TRISS) probability of survival, revised trauma scores (5.9), age, ambulance times, preinfusion blood pressure, and etiology distribution were identical between groups. The total amount of fluid administered, white blood cell count, arterial blood gases, potassium, or bicarbonate also were identical between groups. The HSD group had an improved blood pressure (p = 0.024). Hematocrit, sodium chloride, and osmolality levels were significantly elevated in the Emergency Center. Although no difference in overall survival was demonstrated, the HSD group requiring surgery did have a better survival (p = 0.02), with some variance among centers. The HSD group had fewer complications that the standard treatment group (7 versus 24). A greater incidence of adult respiratory distress syndrome, renal failure, and coagulopathy occurred in the standard treatment group. No anaphylactoid nor Dextran-related coagulopathies occurred in the HSD group. Although this trial demonstrated trends supportive of HSD in hypotensive hemorrhagic shock patients requiring surgery, a larger sample size will be required to establish which subgroups of trauma patients might maximally benefit from the prehospital use of a small volume of hyperosmolar solution. This study demonstrates the safety of administering 250 mL 7.5% HDS to this group of patients.

PMID: 1708984 [PubMed - indexed for MEDLINE]

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Mitomycin C as an adjuvant treatment to resected gastric cancer. A 10-year follow-up.

Ann Surg. 1991 Mar;213(3):219-21

Authors: Estape J, Grau JJ, Lcobendas F, Curto J, Daniels M, Viñolas N, Pera C

Seventy consecutive patients were entered in a two-arm randomized trial after surgical resection for locally advanced gastric cancer. In the first arm, 37 patients were included as a control group, receiving no further treatment after surgery. In the second arm, 33 patients were treated with adjuvant chemotherapy consisting of mitomycin C (MMC), 20 mg/m2 administered intravenously once every 6 weeks for four consecutive cycles. All patients in both arms were followed in the same way for 5 years. At 5 years 23 of 37 patients in the control arm and 7 of 33 patients in the treatment arm were dead because of relapse. Actuarial survival curve was statistically significant in favor of patients given adjuvant MMC (p less than 0.001). After 10 years follow-up, 31 of 37 patients in the control arm and 16 out of 33 patients in the treatment arm were dead because of relapse, the statistical differences continuing in the actuarial survival curve in favor of treated patients (p less than 0.01). The best advantages of adjuvant treatment were observed in the T3N0M0 stage. The most frequent relapse site was the peritoneal cavity and the relapse pattern shows special decrease in liver metastases in treated patients. Toxicity was acute and mild. No delayed toxicity or second malignancies were observed. These data suggest that adjuvant MMC after resected surgery of gastric cancer is a successful treatment and its effects are still evident after 10 years of follow-up.

PMID: 1900148 [PubMed - indexed for MEDLINE]

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Immunomodulatory therapy with thymopentin and indomethacin. Successful restoration of interleukin-2 synthesis in patients undergoing major surgery.

Ann Surg. 1991 Sep;214(3):264-73; discussion 274-5

Authors: Faist E, Markewitz A, Fuchs D, Lang S, Zarius S, Schildberg FW, Wachter H, Reichart B

Prostaglandin E2 (PGE2)-mediated monocyte (M phi) suppressor activity and inadequate T-helper cell function represent the mechanistic keystones of trauma-induced impairment of cell-mediated immunity (CMI). In a prospective randomized trial, the immunorestorative potential of a combined therapy with the thymomimetic substance Thymopentin (TP-5; Timunox, Cilag GMBH, Sulzbach, FRG) and the cyclooxygenase inhibitor indomethacin (Indo) in 60 patients (mean age, 63 +/- 2 years) undergoing open heart surgery was studied. Perioperative immunologic screening was carried out on days -2, 3, 1, 5, and 7 and included the in vivo delayed type hypersensitivity (DTH) skin response, phenotyping for peripheral blood mononuclear cell (PBMC)-specific and nonspecific induction of lymphoproliferative responses, in vitro interleukin-2 (IL-2) synthesis, as well as the serum concentration of D-erythro-Neopterin (NPT) and of gamma interferon (gamma-IFN). The study protocol comprised three groups (n = 20): PA (Indo 150 mg administered intravenously on days 0 to 5), PB (TP-5 administered subcutaneously on days 0, 2, 4, and Indo), and PC (control). In contrast to PC, significant immunorestoration could be demonstrated in PB, as DTH scores on day 7, as well as proliferative responses in cell cultures were not depressed after operation (p less than 0.05). Cell-surface receptor expression for the CD3+, CD4+, and IL-2 receptor-positive (IL-2R+) lymphocyte subpopulations following surgery was reduced to 75% of baseline values in PC, while in PB, receptor protection for CD4+ and IL-2R+ subpopulations (more than 15% above baseline) was observed. Interleukin-2 synthesis (average baseline value, 0.7 + 0.08 U/mL) in cell cultures of PC was massively suppressed, with lymphokine concentrations in the supernatants never more than 0.27 +/- 0.05 U/mL. In PA cultures, IL-2 synthesis was impaired as well but not as precipitously as in PC. In contrast, in PB cultures, the average IL-2 production on consecutive postoperative days was never below baseline values. This study clearly demonstrates that the combined Indo/TP-5 therapy is superior to single Indo administration and can adequately preserve and/or restore intact M phi T-cell interaction and thus appears to be a feasible approach to maintain normal host defense activity in traumatized individuals.

PMID: 1929608 [PubMed - indexed for MEDLINE]

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Factors affecting morbidity following hepatic trauma. A prospective analysis of 482 injuries.

Ann Surg. 1991 Jun;213(6):540-7; discussion 548

Authors: Fabian TC, Croce MA, Stanford GG, Payne LW, Mangiante EC, Voeller GR, Kudsk KA

During a 5-year period, 482 patients with liver injuries were studied prospectively: 65% resulted from penetrating and 35% from blunt injuries. The injuries were graded by the hepatic injury scale (grades I to VI); transfusion requirements and perihepatic abscesses correlated with increasing scores. Minor surgical techniques were needed in 338 patients and 144 patients required major techniques. Omental packing was used in 60% of the major injuries and yielded 7% mortality and 8% abscess rates. Gauze packs were used for management of 10% of major injuries and yielded 29% mortality and 30% abscess rates. The patients were randomized to no drain, closed suction, or sump drainage and respective perihepatic abscess rates were 6.7%, 3.5%, and 13% (p less than 0.03; suction compared to closed suction). Multivariate analysis demonstrated increasing abdominal trauma indices and transfusion requirements as well as sump drainage to be associated independently with perihepatic infection.

PMID: 2039284 [PubMed - indexed for MEDLINE]

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Glutamine-enriched intravenous feedings attenuate extracellular fluid expansion after a standard stress.

Ann Surg. 1991 Oct;214(4):385-93; discussion 393-5

Authors: Scheltinga MR, Young LS, Benfell K, Bye RL, Ziegler TR, Santos AA, Antin JH, Schloerb PR, Wilmore DW

A double-blind, randomized controlled trial was performed to determine the effect of glutamine (GLN)-enriched intravenous feedings on the volume and distribution of body fluids in catabolic patients. Subjects with hematologic malignancies in remission underwent a standard treatment of high-dose chemotherapy and total body irradiation before bone marrow transplantation. After completion of this regimen, they were randomized to receive either standard parenteral nutrition (STD, n = 10) or an isocaloric, isonitrogenous nutrient solution enriched with crystalline L-glutamine (0.57 g/kg/day, GLN, n = 10). Extracellular water (ECW) and total body water (TBW), determined by bromide and heavy water dilution techniques, were measured before the conditioning treatment and after termination of the intravenous feedings that were administered for 27 +/- 1 days. In addition electrical resistance (R, in ohms, omega) and reactance (Xc, omega) of the body to a weak alternating current were measured at these time points. Both study groups were comparable for age, weight, height, sex, and diagnosis. Initial TBW was highly related to electrical resistance (r = -0.93, p less than 0.001). After conditioning therapy, bone marrow infusion, and intravenous feedings, a 20% expansion in ECW was observed in the STD group (ECW: 18.0 +/- 1.1 L vs. 14.9 +/- 1.0, p = 0.012), and this fluid retention was associated with a marked decrease in electrical resistance (R: 514 +/- 28 omega vs. 558 +/- 26, p less than 0.05). In contrast the extracellular fluid compartment in patients receiving GLN-supplementation did not change (ECW: 15.8 +/- 0.9 L vs. 15.4 +/- 0.8, p = 0.49), and the body’s resistance was maintained (R: 552 +/- 27 omega vs. 565 +/- 23, p = 0.42). Expansion of ECW could not be related to differences in fluid or sodium intake, or to the use of diuretics or steroids. Patients receiving the STD solution, however, exhibited a greater number of positive microbial cultures (p less than 0.01) and a higher rate of clinical infection compared with the GLN patients (5/10 vs. 0/10, p less than 0.05); the fluid expansion in infected STD patients was greater compared with uninfected individuals (delta ECW: + 5.0 +/- 1.4 vs. 0.7 +/- 0.5, p = 0.007). In this model of catabolic stress, fluid retention and expansion of the extracellular fluid compartment commonly observed after standard total parenteral nutrition can be attenuated by administering glutamine-supplemented intravenous feedings, possibly by protecting the host from microbial invasion and associated infection.

PMID: 1953094 [PubMed - indexed for MEDLINE]

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Preoperative optimization of cardiovascular hemodynamics improves outcome in peripheral vascular surgery. A prospective, randomized clinical trial.

Ann Surg. 1991 Sep;214(3):289-97; discussion 298-9

Authors: Berlauk JF, Abrams JH, Gilmour IJ, O’Connor SR, Knighton DR, Cerra FB

The hypothesis that optimizing hemodynamics using pulmonary artery (PA) catheter (preoperative ‘tune-up’) would improve outcome in patients undergoing limb-salvage arterial surgery was tested. Eighty-nine patients were randomized to preoperative tune-up either in the surgical intensive care unit (SICU) (group 1) or the preinduction room (group 2) or to control (group 3). The tune-up consisted of fluid loading, afterload reduction, and/or inotropic support to achieve predetermined endpoints. Patients with a PA catheter had significantly fewer adverse intraoperative events (p less than 0.05), less postoperative cardiac morbidity (p less than 0.05), and less early graft thrombosis (p less than 0.05) than the control group. The overall study mortality rate was 3.4%, with a mortality rate of 9.5% in the control group and 1.5% in the PA catheter groups. There were no differences in ICU length of stay (LOS), hospital LOS, or total hospital costs, although the percentage of cost from complications was higher in group 3 (p greater than 0.05). In this group of patients, preoperative cardiac assessment and optimization is associated with improved outcome.

PMID: 1929610 [PubMed - indexed for MEDLINE]

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Enteral versus parenteral feeding. Effects on septic morbidity after blunt and penetrating abdominal trauma.

Ann Surg. 1992 May;215(5):503-11; discussion 511-3

Authors: Kudsk KA, Croce MA, Fabian TC, Minard G, Tolley EA, Poret HA, Kuhl MR, Brown RO

To investigate the importance of route of nutrient administration on septic complications after blunt and penetrating trauma, 98 patients with an abdominal trauma index of at least 15 were randomized to either enteral or parenteral feeding within 24 hours of injury. Septic morbidity was defined as pneumonia, intra-abdominal abscess, empyema, line sepsis, or fasciitis with wound dehiscence. Patients were fed formulas with almost identical amounts of fat, carbohydrate, and protein. Two patients died early in the study. The enteral group sustained significantly fewer pneumonias (11.8% versus total parenteral nutrition 31.%, p less than 0.02), intra-abdominal abscess (1.9% versus total parenteral nutrition 13.3%, p less than 0.04), and line sepsis (1.9% versus total parenteral nutrition 13.3%, p less than 0.04), and sustained significantly fewer infections per patient (p less than 0.03), as well as significantly fewer infections per infected patient (p less than 0.05). Although there were no differences in infection rates in patients with injury severity score less than 20 or abdominal trauma index less than or equal to 24, there were significantly fewer infections in patients with an injury severity score greater than 20 (p less than 0.002) and abdominal trauma index greater than 24 (p less than 0.005). Enteral feeding produced significantly fewer infections in the penetrating group (p less than 0.05) and barely missed the statistical significance in the blunt-injured patients (p = 0.08). In the subpopulation of patients requiring more than 20 units of blood, sustaining an abdominal trauma index greater than 40 or requiring reoperation within 72 hours, there were significantly fewer infections per patient (p = 0.03) and significantly fewer infections per infected patient (p less than 0.01). There is a significantly lower incidence of septic morbidity in patients fed enterally after blunt and penetrating trauma, with most of the significant changes occurring in the more severely injured patients. The authors recommend that the surgeon obtain enteral access at the time of initial celiotomy to assure an opportunity for enteral delivery of nutrients, particularly in the most severely injured patients.

PMID: 1616387 [PubMed - indexed for MEDLINE]

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Stress ulcers and organ failure in intubated patients in surgical intensive care units.

Ann Surg. 1992 Apr;215(4):332-7

Authors: Martin LF, Booth FV, Reines HD, Deysach LG, Kochman RL, Erhardt LJ, Geis GS

This study compared prophylactic administration of either intragastric misoprostol (200 micrograms four times a day), a prostaglandin E1 analog, or bolus intravenous cimetidine (300 mg every 6 hours) in preventing stress lesions and stress bleeding in 127 adult postoperative patients who required mechanical ventilation and also had developed hypotension or sepsis. Both drug treatments were equally effective in preventing the development of diffuse gastritis (greater than 10 gastric hemorrhagic lesions) and in preventing upper gastrointestinal hemorrhage (UGIH). The combined data from both groups showed that for the 44 (35%) patients who died, death was significantly associated with the presence at study entry of renal failure (64% of 25 patients with renal failure died), hepatic failure (57% of 23 patients) or coagulopathy (62% of 29 patients) (p less than 0.02 for each), and with the number of organ system failures at study entry (48% of 69 patients with multiple organ system failures died, p less than 0.001). Death was also significantly associated with the presence of adult respiratory distress syndrome (ARDS) at study entry or the development of ARDS (63% of 24 patients with ARDS died, p less than 0.001), and the development of UGIH (5% of 93 patients with known bleeding outcome died, p less than 0.05). The number of stress lesions that developed was significantly associated with subsequent UGIH (p less than 0.001). Additional organ system failure developed during the study in 31% of the 127 patients, as did diffuse gastritis in 20% of 111 patients who had a follow-up endoscopy. These results demonstrate that postoperative patients who require mechanical ventilation and have hypotension or sepsis are at significant risk for the development of stress gastric lesions and multiple organ system failure even when prophylaxis for stress ulcers is provided. Furthermore, the presence of ARDS, renal failure, hepatic failure, coagulopathy, and UGIH are significantly associated with death.

PMID: 1558413 [PubMed - indexed for MEDLINE]

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Pancreatic resection versus peritoneal lavage in acute necrotizing pancreatitis. A prospective randomized trial.

Ann Surg. 1991 Dec;214(6):663-6

Authors: Schröder T, Sainio V, Kivisaari L, Puolakkainen P, Kivilaakso E, Lempinen M

Twenty-one patients with acute fulminant alcoholic pancreatitis were randomly allocated to either pancreatic resection group (11 patients) or nonoperative peritoneal lavage group (10 patients). Only patients under 50 years were included in the study to minimize the role of other severe disease. These patients represented the most severe cases of acute pancreatitis at our Department, constituting only 2% of all patients with acute pancreatitis during this period. The diagnosis was based on clinical symptoms and on signs indicating severely impaired systemic organ functions. All patients underwent contrast-enhanced computed tomography (CT), which showed contrast enhancement below 30 Hounsfield units. In the operated cases, the diagnosis of necrotizing pancreatitis was verified histologically. All patients with conservative treatment had dark brown fluid at peritoneal puncture. There was a difference (nonsignificant) in mortality (3/11 and 1/10, respectively), complication rate, or in the need of reoperations between the groups. Nonoperative peritoneal lavage was followed with shorter treatment at the intensive care unit (16.2 versus 25.9 days, respectively). The hospital stay also was significantly shorter in the nonoperative group (44.3 versus 56.1 days). The results indicate that intensive conservative treatment is justified as an initial therapy even in the most severe cases of acute pancreatitis.

PMID: 1741645 [PubMed - indexed for MEDLINE]

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Biosynthetic human growth hormone preserves both muscle protein synthesis and the decrease in muscle-free glutamine, and improves whole-body nitrogen economy after operation.

Ann Surg. 1992 Aug;216(2):184-91

Authors: Hammarqvist F, Strömberg C, von der Decken A, Vinnars E, Wernerman J

As a reproducible human trauma model, patients (n = 17) undergoing elective cholecystectomy were studied for 3 postoperative days. They were randomly allocated to receive either recombinant human growth hormone (hGH; 0.3 U/kg/24 hours) or placebo together with total parenteral nutrition, including 0.2 gN/kg/24 hours and 135 kJ/kg/24 hours. Before operation and on the third postoperative day, percutaneous muscle biopsies were performed to determine the concentration and size distribution of ribosomes and the free amino acid concentrations. The significant postoperative decrease in the total ribosome concentration (15.3 +/- 6.4%) and the polyribosome concentration (20.9 +/- 6.5%) in the control group was impeded in the group receiving synthetic hGH. Muscle free glutamine decreased by 35.6 +/- 4.2% in the control group and to a lesser extent in the group that was given hGH after operation (p less than 0.05). The protein content of skeletal muscle was unchanged. The cumulated nitrogen balance for the study period was negative in the control group (-7.09 +/- 0.71 gN), but was not different from zero in the hGH group (-2.32 +/- 1.66 gN). It is concluded that synthetic hGH administered after operation has beneficial effects on the whole-body nitrogen economy, as indicated by the unchanged capacity for protein synthesis in skeletal muscle, the preserved levels of muscle free glutamine, and improvement in the whole-body nitrogen balance. The effects of hGH on skeletal muscle protein and amino acid metabolism can explain the postoperative nitrogen-sparing effect attributed to hGH.

PMID: 1503519 [PubMed - indexed for MEDLINE]

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The safety and effect of topically applied recombinant basic fibroblast growth factor on the healing of chronic pressure sores.

Ann Surg. 1992 Oct;216(4):401-6; discussion 406-8

Authors: Robson MC, Phillips LG, Lawrence WT, Bishop JB, Youngerman JS, Hayward PG, Broemeling LD, Heggers JP

The first randomized, blinded, placebo-controlled human trials of recombinant basic fibroblast growth factor (bFGF) for pressure sore treatment were performed. Three different concentrations of bFGF in five dosing schedules were tested for safety using hematology, serum chemistries, urinalysis, absorption, antibody formation, and signs of toxicity. Efficacy was evaluated by wound volumes, histology, and photography. No toxicity, significant serum absorption, or antibody formation occurred. In six of eight subgroups, there was a trend toward efficacy with bFGF treatment. When all subgroups were combined, comparison of the slopes of the regression curves of volume decrease over initial pressure sore volume demonstrated a greater healing effect for the bFGF-treated patients (p < 0.05). Histologically, bFGF-treated wound sections demonstrated increased fibroblasts and capillaries. More patients treated with bFGF achieved > 70% wound closure (p < 0.05). Blinded observers were able to distinguish differences in visual wound improvement between bFGF and placebo groups. These data suggest that bFGF may be effective in the treatment of chronic wounds.

PMID: 1417189 [PubMed - indexed for MEDLINE]

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Effect of intraportal glucose infusion on hepatic glycogen content and degradation, and outcome of liver transplantation.

Ann Surg. 1992 Sep;216(3):235-46; discussion 246-7

Authors: Cywes R, Greig PD, Sanabria JR, Clavien PA, Levy GA, Harvey PR, Strasberg SM

Recent animal studies suggest that nutritional repletion may improve function of liver allografts, and the authors have found that intraportal glucose infusion in pigs produces rapid and substantial hepatic glycogenation. A controlled prospective randomized study in 32 patients was done to determine glycogen content and degradation in human livers during transplantation, and the effect of intraportal glucose-insulin infusions during the donor operation on these variables and on outcome of transplantation. Peripheral blood glucose concentrations were “clamped” at 14 mmol/L during the glucose-insulin infusion. Liver biopsies were taken at various stages of the procedure. Liver glycogen decreased 2.0 +/- 1.2 g/100 g dry weight liver (mean +/- standard error of the mean) in controls, but increased 6.8 +/- 1.8 g/100 g dry weight in glucose-infused donors. In both groups there was glycogen degradation during periods of cold preservation, anoxic rewarming, and after reperfusion with portal blood. Degradation rates were greater in the glucose-infused group than in controls in all three periods (p less than 0.05). Despite wide variation in postoperative aspartate aminotransferase (AST) levels among recipients in both groups, the difference in peak postoperative AST levels approached significance (p = 0.06). In addition, peak AST levels were closely correlated to anoxic rewarming time in both groups, but the slope of the relationship was much lower (3834 versus 734, p less than 0.01) in the glucose-infused group. Thus at anoxic rewarming times over 90 minutes, glycogenation was protective of liver function. Peak postoperative AST was significantly correlated to glycogen degradation in the cold preservation and rewarming periods in the glucose-infused group only. Intraoperative glucose infusions in humans can reglycogenate the liver, increase glycogen degradation, and improve certain outcome measures in liver transplantation.

PMID: 1417173 [PubMed - indexed for MEDLINE]

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Intestinal transplantation in composite visceral grafts or alone.

Ann Surg. 1992 Sep;216(3):223-33; discussion 233-4

Authors: Todo S, Tzakis AG, Abu-Elmagd K, Reyes J, Nakamura K, Casavilla A, Selby R, Nour BM, Wright H, Fung JJ

Under FK 506-based immunosuppression, the entire cadaver small bowel except for a few proximal and distal centimeters was translated to 17 randomly matched patients, of whom two had antigraft cytotoxic antibodies (positive cross-match). Eight patients received the intestine only, eight had intestine in continuity with the liver, and one received a full multivisceral graft that included the liver, stomach, and pancreas. One liver-intestine recipient died after an intestinal anastomotic leak, sepsis, and graft-versus-host disease. The other 16 patients are alive after 1 to 23 months, in one case after chronic rejection, graft removal, and retransplantation. Twelve of the patients have been liberated from total parenteral nutrition, including all whose transplantation was 2 months or longer ago. The grafts have supported good nutrition, and in children, have allowed growth and weight gain. Management of these patients has been difficult and often complicated, but the end result has been satisfactory in most cases, justifying further clinical trials. The convalescence of the eight patients receiving intestine only has been faster and more trouble free than after liver-intestine or multivisceral transplantation, with no greater difficulty in the control of rejection.

PMID: 1384443 [PubMed - indexed for MEDLINE]

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Effects of recombinant human growth hormone in patients with severe sepsis.

Ann Surg. 1992 Dec;216(6):648-55

Authors: Voerman HJ, van Schijndel RJ, Groeneveld AB, de Boer H, Nauta JP, van der Veen EA, Thijs LG

The objective of this study was to evaluate the safety and the effect of recombinant exogenous growth hormone (GH) on nitrogen production in patients with severe sepsis. It was designed as a prospective, randomized, placebo-controlled trial, and performed in the medical intensive care unit of a university hospital. Twenty patients admitted with septic shock and receiving standard parenteral nutrition served as subjects. Treatment consisted of GH 0.1 mg/kg/day or placebo administered as continuous intravenous infusion on the second, third, and fourth days after admission. The study period was eight days. During GH administration, nitrogen production decreased significantly in the GH group and increased in controls (p < 0.01). Nitrogen balance became slightly positive in the GH group during treatment: 1.2 +/- 6.4 versus controls -3.7 +/- 3.8 g/day (day 3) (p < 0.05). Within 24 hours after cessation of treatment, differences between GH and controls disappeared. 3-Methylhistidine excretion as a measure of absolute muscle breakdown declined during the study period, but did not differ between groups. The levels of insulin, insulinlike growth factor 1, glycerol, free fatty acids, and beta-hydroxybutyrate increased during treatment. Despite continuous intravenous administration, GH levels gradually declined during the 3 treatment days, indicating increased metabolic clearance. Side effects other than insulin resistance were not observed. Growth hormone administration reduces nitrogen production and improves nitrogen balance in patients with severe sepsis. These effects are not sustained after cessation of treatment.

PMID: 1466618 [PubMed - indexed for MEDLINE]

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Prolongation of survival in metastatic melanoma after active specific immunotherapy with a new polyvalent melanoma vaccine.

Ann Surg. 1992 Oct;216(4):463-82

Authors: Morton DL, Foshag LJ, Hoon DS, Nizze JA, Famatiga E, Wanek LA, Chang C, Davtyan DG, Gupta RK, Elashoff R

A new polyvalent melanoma cell vaccine (MCV) was administered to 136 stage IIIA and IV (American Joint Committee on Cancer) melanoma patients. Induction of cell-mediated and humoral immune responses to common melanoma-associated antigens present on autologous melanoma cells was observed in patients receiving the new MCV. This was accompanied by increased activation of tumor-infiltrating lymphocytes. Survival correlated significantly with delayed cutaneous hypersensitivity (p = 0.0066) and antibody responses to MCV (p = 0.0117). Of 40 patients with evaluable disease, nine (23%) had regressions (three complete). From our historical database of 126 stage IIIA and 1275 stage IV melanoma patients, there were no significant changes in the natural history of metastatic melanoma during the past 20 years. Univariate and multivariate analyses demonstrated prognostic significance for site of metastases (p = 0.0001) and immunotherapy with the new MCV (p = 0.0001). Overall our new MCV increased the median and 5-year survival of stage IIIA melanoma patients with regional soft tissue metastases twofold (p = 0.00024), and stage IV patients threefold (p = 0.0001) compared with previous immunotherapy and other treatments.

PMID: 1417196 [PubMed - indexed for MEDLINE]

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The effect of postoperative intravenous feeding (TPN) on outcome following major surgery evaluated in a randomized study.

Ann Surg. 1993 Feb;217(2):185-95

Authors: Sandström R, Drott C, Hyltander A, Arfvidsson B, Scherstén T, Wickström I, Lundholm K

Three hundred patients undergoing major general surgical procedures were randomized by means of a computer-assisted algorithm to receive either total parenteral nutrition (TPN) from the first postoperative day or only prolonged glucose administration (250-300 g/day) up to 15 days after operation. All patients receiving TPN were treated individually based on daily measurements of energy and nitrogen balances. The treatment goal was to keep the patients in positive energy balance (+20%) and close to nitrogen balance. The effects of the two “nutrition regimens” on outcome such as mortality rate, complications, the need of additional medical support and patient-related functional disabilities were investigated. No selection of patients was made, that is, malnourished patients were also randomized. There were no differences among TPN versus glucose treatment when results were analyzed according to intent to treat. Approximately 60% of all patients were able to start eating within 8 to 9 days after operation. No differences were observed between such patients regardless of being treated with TPN or glucose only. Patients on glucose treatment during 14 days had a significantly higher mortality rate (p < 0.05) than patients on either continuous and uncomplicated TPN treatment or short-term glucose treatment. Similar results for mortality rates also were seen with regard to severe complications (cardiopulmonary problems, sepsis, and wound-healing insufficiencies), functional disturbances, the need of additional medical support, and abnormalities in nutritional state. Twenty per cent of the patients randomized to TPN treatment showed a statistical trend (p < 0.10) toward a higher mortality rate (36%) compared with patients randomized to prolonged glucose treatment (21% mortality rate). These patients could not be identified by evaluation of preoperative factors. Thus, the overall evaluation of the results makes it likely that a fraction of high-risk patients (approximately 20%) were not doing well on immediate postoperative intravenous feeding, and it is possible that TPN to such patients accentuated their morbidity rate. Although patients (20%) on prolonged semi-starvation (14 days glucose treatment) had increased mortality rate and severe complications, it was possible that undernutrition induced a slightly different complication scenario than induced by TPN in the high-risk patients. The results demonstrate that in most surgical patients (60%), postoperative semi-starvation is not a limiting factor for outcome. In remaining 40%, inadequate nutrition was associated with both increased morbidity and mortality rates. In this sense, inadequate nutrition represents both too much and too little, whereas overfeeding seemed to be a larger problem than underfeeding.(ABSTRACT TRUNCATED AT 400 WORDS)

PMID: 8439216 [PubMed - indexed for MEDLINE]

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Efficacy of a beta-lactamase inhibitor combination for serious intraabdominal infections.

Ann Surg. 1993 Feb;217(2):115-21

Authors: Walker AP, Nichols RL, Wilson RF, Bivens BA, Trunkey DD, Edmiston CE, Smith JW, Condon RE

A double-blind trial was conducted in 385 patients with suspected bacterial intra-abdominal infections to compare the efficacy and safety of ampicillin-sulbactam with cefoxitin. Patients were randomized to receive either 3 g ampicillin-sulbactam (2 g ampicillin-1 g sulbactam), or 2 g cefoxitin, every 6 hours. To be evaluable, patients had to demonstrate positive culture evidence of peritoneal infection at the time of operation. A total of 197 patients were evaluable for clinical efficacy. The two treatment groups were comparable in demographic features and in the presence of risk factors for infection. Clinical success (absence of infection and of adverse drug reaction) was observed in 86% of patients in the ampicillin-sulbactam group and 78% in the cefoxitin group. Eradication of infection occurred in 88% of the ampicillin-sulbactam group and 79% of the cefoxitin group. There were no differences in the nature or frequency of side effects observed in the two groups. Ampicillin-sulbactam demonstrated no difference in safety or efficacy when compared with cefoxitin in the treatment of serious intra-abdominal infections of bacterial origin.

PMID: 8439209 [PubMed - indexed for MEDLINE]

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Effect of total parenteral nutrition on amino acid and glucose transport by the human small intestine.

Ann Surg. 1993 Jun;217(6):604-12; discussion 612-4

Authors: Inoue Y, Espat NJ, Frohnapple DJ, Epstein H, Copeland EM, Souba WW

OBJECTIVE: The effect of total parenteral nutrition (TPN) on small intestinal amino acid transport activity was studied in humans. SUMMARY BACKGROUND DATA: Studies in humans receiving TPN indicate that a decrease in the activities of the dissacharidase enzymes occurs, but morphologic changes are minimal with only a slight decrease in villous height. METHODS: Surgical patients were randomized to receive TPN (n = 6) or a regular oral diet (controls, n = 7) for 1 week before abdominal surgery. Ileum (5 controls, 5 TPN) or jejunum (2 controls, 1 TPN) were obtained intraoperatively and brush-border membrane vesicles (BBMV) were prepared by magnesium aggregation/differential centrifugation. Transport of L-MeAlB (a selective system A substrate), L-glutamine, L-alanine, L-arginine, L-leucine, and D-glucose was assayed by a rapid mixing/filtration technique in the presence and absence of sodium. RESULTS: Vesicles demonstrated approximately 18-fold enrichments of enzyme markers, classic overshoots, transport into an osmotically active space, and similar 1-hour equilibrium values. TPN resulted in a 26-44% decrease in the carrier-mediated transport velocity of all substrates except glutamine across ileal BBMVs. In the one patient receiving TPN from whom jejunum was obtained, there was also a generalized decrease in nutrient transport, although glutamine was least affected. Kinetic studies of the system A transporter demonstrated that the decrease in uptake was secondary to a reduction in carrier Vmax, consistent with a decrease in the number of functional carriers in the brush-border membrane. CONCLUSIONS: TPN results in a decrease in brush-border amino acid and glucose transport activity. The observation that glutamine transport is not downregulated by 1 week of bowel rest may further emphasize the important metabolic role that glutamine plays as a gut fuel and in the body’s response to catabolic stresses.

PMID: 8507109 [PubMed - indexed for MEDLINE]

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Experience with mycophenolate mofetil (RS61443) in renal transplantation at a single center.

Ann Surg. 1993 May;217(5):476-82; discussion 482-4

Authors: Deierhoi MH, Kauffman RS, Hudson SL, Barber WH, Curtis JJ, Julian BA, Gaston RS, Laskow DA, Diethelm AG

OBJECTIVE: Mycophenolate mofetil (MM) is a new immunosuppressive agent that reversibly inhibits guanine nucleotide synthesis and DNA replication. Its activity is highly selective for T and B lymphocytes. Two open-label multicenter trials of MM in renal transplantation have been performed. This report summarizes the results from one center involved in these two trials. METHODS AND RESULTS: The initial trial of MM was an open-label dose-ranging trial in primary cadaveric renal transplantation. Mycophenolate mofetil was included in the maintenance immunosuppression regimen from the day after transplantation. Of the 21 patients enrolled in this trial, one (5%) was withdrawn for side effects. There was one graft loss due to recurrent renal disease and two patients were withdrawn for difficulty with follow-up. Mean follow-up is 26 months, and patient and graft survival at 2 years are 100 and 95% respectively. The second trial was designed to study the efficacy of mycophenolate in reversing refractory renal allograft rejection. Patients enrolled in the trial had biopsy-proven acute rejection and had previously received at least one course of high-dose corticosteroids and/or OKT3. Of the 26 patients enrolled in this trial, one (4%) was withdrawn for side effects. There were two deaths. Mean follow-up is 20 months, and patient and graft survival at 12 months was 91 and 54%. The incidence of infections in the two groups was 38% and there were no deaths in either group attributable to infection. CONCLUSIONS: The results of these two studies indicate that mycophenolate mofetil could be administered safely to renal allograft recipients for periods up to 2 years. It appears to be effective in reversing acute rejection in a high percentage of patients refractory to other forms of therapy.

PMID: 8489310 [PubMed - indexed for MEDLINE]

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Erythromycin accelerates gastric emptying after pancreaticoduodenectomy. A prospective, randomized, placebo-controlled trial.

Ann Surg. 1993 Sep;218(3):229-37; discussion 237-8

Authors: Yeo CJ, Barry MK, Sauter PK, Sostre S, Lillemoe KD, Pitt HA, Cameron JL

OBJECTIVE: This study tested the hypothesis that erythromycin, a motilin agonist, reduces the incidence of early DGE after pancreaticoduodenectomy. SUMMARY BACKGROUND DATA: Delayed gastric emptying (DGE) is a leading cause of morbidity after pancreaticoduodenectomy, occurring in up to 40% of patients. The pathogenesis of DGE has been speculated to involve factors such as peritonitis from anastomotic leaks, ischemia to the antropyloric muscles, and gastric atony in response to resection of the duodenal pacemaker or reduction in circulating motilin levels. METHODS: Between November 1990 and January 1993, 118 patients undergoing pancreaticoduodenectomy completed this prospective, randomized, placebo-controlled trial. The patients received either 200 mg of intravenous erythromycin lactobionate every 6 hours (n = 58), or an identical volume of 0.9% saline (n = 60) from the third to tenth postoperative days. On the tenth postoperative day, a dual phase radionuclide gastric emptying study was performed. RESULTS: The erythromycin and control groups were comparable regarding multiple preoperative, intraoperative, and postoperative factors. The erythromycin group had a 37% reduction in the incidence of DGE (19% vs. 30%), a significantly reduced (p < 0.05) need to reinsert a nasogastric tube for DGE (6 vs. 15 patients), and a significantly reduced (p < 0.01) per cent retention of liquids at 30 minutes and solids at 30, 60, 90, and 120 minutes. No major adverse reactions to erythromycin were observed. CONCLUSIONS: Erythromycin is a safe, inexpensive drug that significantly accelerates gastric emptying after pancreaticoduodenectomy and reduces the incidence of DGE by 37%. These data support the use of erythromycin to decrease early DGE after pancreaticoduodenectomy.

PMID: 8103982 [PubMed - indexed for MEDLINE]

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A prospective, randomized evaluation of the effect of silver impregnated subcutaneous cuffs for preventing tunneled chronic venous access catheter infections in cancer patients.

Ann Surg. 1993 Aug;218(2):206-10

Authors: Groeger JS, Lucas AB, Coit D, LaQuaglia M, Brown AE, Turnbull A, Exelby P

OBJECTIVE: This study was performed to evaluate the effect of a silver-impregnated cuff on the incidence of catheter-related bacteremia/fungemia or tunnel tract infection in cancer patients with chronic dual-lumen tunneled venous access catheters. SUMMARY BACKGROUND DATA: Infection is a frequent and potentially life-threatening complication of tunneled chronic cuffed silastic central venous access catheters in cancer patients. Recent experience with antimicrobial silver-impregnated cuffs placed on nontunneled percutaneously inserted central venous catheters suggests that such a cuff may render the catheter less prone to infection. METHODS: The authors prospectively randomized 200 cancer patients to receive either a dual-lumen 10 French tunneled cuffed silastic central venous access catheter or the same catheter with a second more proximal subcutaneous silver-impregnated cuff. All patients then were followed prospectively for infectious morbidity until the device was removed or the patient died. RESULTS: The hazard rate for infection/day (95% confidence limits) was 0.0022 (0.0015 to 0.0030) for standard catheters compared with 0.0027 (0.0019 to 0.0037) for catheters with silver-impregnated cuffs (p = not significant). Regression analysis of infection-free interval of both catheter types shows no difference over the lifetime of catheter as well as the over the first 48 days after insertion. CONCLUSIONS: The study indicated no effect of a silver-impregnated cuff in decreasing the incidence of catheter-related bacteremias/fungemias, tunnel infections, or the spectrum of causative microorganisms involved in cancer patients with tunneled chronic venous access catheters.

PMID: 8343002 [PubMed - indexed for MEDLINE]

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Efficacy of 2-cm surgical margins for intermediate-thickness melanomas (1 to 4 mm). Results of a multi-institutional randomized surgical trial.

Ann Surg. 1993 Sep;218(3):262-7; discussion 267-9

Authors: Balch CM, Urist MM, Karakousis CP, Smith TJ, Temple WJ, Drzewiecki K, Jewell WR, Bartolucci AA, Mihm MC, Barnhill R

BACKGROUND: A prospective, multi-institutional, randomized surgical trial involving 486 localized melanoma patients was conducted to determine whether excision margins for intermediate-thickness melanomas (1.0 to 4.0 mm) could be safely reduced from the standard 4-cm radius. METHODS: Patients with 1- to 4-mm-thick melanomas on the trunk or proximal extremities were randomly assigned to receive either a 2- or 4-cm surgical margin. RESULTS: The median follow-up time was 6 years. The local recurrence rate was 0.8% for 2-cm margins and 1.7% for 4-cm margins (p value not significant [NS]). The rates of in-transit metastases were 2.1% and 2.5%, respectively (p = NS). Of the six patients with local recurrences, five have died. Recurrence rates did not correlate with surgical margins, even among stratified thickness groups. The overall 5-year survival rate was 79.5% for the 2-cm margin patients and 83.7% for the 4-cm margin patients (p = NS). The need for skin grafting was reduced from 46% with 4-cm surgical margins to 11% with 2-cm surgical margins (p < 0.001). The hospital stay was shortened from 7.0 days for patients receiving 4-cm surgical margins to 5.2 days for those receiving 2-cm margins (p = 0.0001). This reduction was largely due to reduced need for skin grafting, since the hospital stay for those who had a skin graft was 2.5 days longer than that for those who had a primary wound closure (p < 0.01). CONCLUSION: Margins of excision can be safely reduced to 2 cm for patients with intermediate-thickness melanomas. The narrower margins significantly reduced the need for skin grafting and shortened the hospital stay.

PMID: 8373269 [PubMed - indexed for MEDLINE]

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A prospective, randomized, blinded, and placebo-controlled trial of intraoperative intra-arterial urokinase infusion during lower extremity revascularization. Regional and systemic effects.

Ann Surg. 1993 Oct;218(4):534-41; discussion 541-3

Authors: Comerota AJ, Rao AK, Throm RC, Skibinski CI, Beck GJ, Ghosh S, Sun L, Curl GR, Ricotta JJ, Graor RA

OBJECTIVE: This study was designed to evaluate the safety and regional and systemic effects of three doses of urokinase (UK) infused into the distal arterial circulation during routine operative lower extremity revascularization. METHODS: One hundred thirty-four patients were prospectively randomized to receive one of three bolus doses of UK (125,000, 250,000, or 500,000 U) or placebo (saline) infused into the distal circulation before lower extremity bypass for chronic limb ischemia. Regional (femoral vein) and systemic (arm) blood was sampled before drug infusion, prereperfusion, and postreperfusion, and systemic blood samples were obtained 2 hours postreperfusion. Assays evaluated plasma levels of fibrinogen, fibrin(ogen) degradation products (FDP), fibrin breakdown products (D-dimer and fragment B-beta 15-42), and plasminogen. Patients were monitored for clinically evident bleeding complications. The Wilcoxon rank-sum test was used to compare different drug doses with the placebo. RESULTS: Intraoperative bolus UK infusions produced no significant fibrinogen breakdown compared with placebo. There was a dose-related decline in plasminogen levels, which became significant at a dose of 500,000 U of UK (p < 0.001). There were dose-related increases in plasma FDP, which became significant at dose of 250,000 and 500,000 U (p < or = 0.005), and in plasma D-dimer, which were significant at all UK doses (p < 0.001). The changes in plasma fibrinogen and markers of fibrin breakdown were similar in the regional and systemic circulations. There was no increase in operative blood loss, blood replaced, or wound hematoma formation. There was an unexplained increased mortality in the placebo group (21.1% vs. 2.0%, p = 0.033). CONCLUSIONS: Intraoperative bolus UK infusion is safe, with no significant fibrinogen depletion or increased operative blood loss or wound hematoma formation. Dose-related plasminogen activation resulted in significant breakdown in cross-linked fibrin in the distal circulation. Intraoperative bolus UK infusion may be valuable as an adjunct in patients with chronic occlusive disease who are undergoing revascularization. Detailed randomized studies are indicated to establish clinical efficacy.

PMID: 8215644 [PubMed - indexed for MEDLINE]

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A prospective randomized trial comparing open versus laparoscopic appendectomy.

Ann Surg. 1994 Jun;219(6):725-8; discussion 728-31

Authors: Frazee RC, Roberts JW, Symmonds RE, Snyder SK, Hendricks JC, Smith RW, Custer MD, Harrison JB

OBJECTIVE: The authors determined whether there was an advantage to laparoscopic appendectomy when compared with open appendectomy. SUMMARY/BACKGROUND DATA: The advantages of laparoscopic appendectomy versus open appendectomy were questioned because the recovery from open appendectomy is brief. METHODS: From January 15, 1992 through January 15, 1993, 75 patients older than 9 years were entered into a study randomizing the choice of operation to either the open or the laparoscopic technique. Statistical comparisons were performed using the Wilcoxon test. RESULTS: Thirty-seven patients were assigned to the open appendectomy group and 38 patients were assigned to the laparoscopic appendectomy group. Two patients were converted intraoperatively from laparoscopic appendectomies to open procedures. Thirty-one patients (81%) in the open group had acute appendicitis, as did 32 patients (84%) in the laparoscopic group. Mean duration of surgery was 65 minutes for open appendectomy and 87 minutes for laparoscopic appendectomy (p < 0.001). There were no statistically significant differences in length of hospitalization, interval until resumption of a regular diet, or morbidity. Duration of both parenteral and oral analgesic use favored laparoscopic appendectomy (2.0 days versus 1.2 days, and 8.0 days versus 5.4 days, p < 0.05). All patients were instructed to return to full activities by 2 weeks postoperatively. This occurred at an average of 25 days for the open appendectomy group versus 14 days for the laparoscopic appendectomy group (p < 0.001). CONCLUSIONS: Patients who underwent laparoscopic appendectomies have a shorter duration of analgesic use and return to full activities sooner postoperatively when compared with patients who underwent open appendectomies. The authors consider laparoscopic appendectomy to be the procedure of choice in patients with acute appendicitis.

PMID: 8203983 [PubMed - indexed for MEDLINE]

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Does the route of feeding modify the inflammatory response?

Ann Surg. 1994 Aug;220(2):155-63

Authors: Santos AA, Rodrick ML, Jacobs DO, Dinarello CA, Wolff SM, Mannick JA, Wilmore DW

OBJECTIVE: The authors compared the responses to endotoxin in enterally and parenterally fed human volunteers. BACKGROUND: Recent investigations have reported that the response to endotoxin in humans is greater in individuals who receive parenteral nutrition rather than enteral feeding. It was proposed that this difference was related to gut barrier dysfunction during intravenous nutrition. To evaluate this hypothesis, the authors analyzed the responses of human subjects to an intravenously administered bolus of endotoxin after enteral or parenteral nutrition. METHODS: Fifteen randomly selected healthy volunteers were studied during two separate investigations; ten studies were performed in ten subjects who received enteral nutrition, and nine studies were carried out in five additional subjects who received parenteral nutrition. After 2 days of enteral feedings or 7 days of parenteral feedings, endotoxin was administered by intravenous injection; temperature, symptom score, and duration then were measured serially. Blood samples were obtained for leukocyte and platelet count, and plasma concentrations of corticotrophin, cortisol, epinephrine, norepinephrine, tumor necrosis factor, and interleukin-6. Mononuclear cell response to phytohemagglutinin was determined at 0, 4, and 24 hours. RESULTS: In the parenteral group, a diminished response was observed in platelet count and plasma interleukin-6 levels compared with volunteers who received enteral nutrition. The duration of symptoms tended to be reduced in the parenterally fed group, although this did not achieve significance. Other responses were not significantly different between the two groups. CONCLUSION: The responses to endotoxin in human subjects who received parenteral nutrition were similar compared with subjects who received enteral nutrition, although platelet count and plasma interleukin-6 concentration were diminished.

PMID: 8053737 [PubMed - indexed for MEDLINE]

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A prospective randomized trial comparing R1 subtotal gastrectomy with R3 total gastrectomy for antral cancer.

Ann Surg. 1994 Aug;220(2):176-82

Authors: Robertson CS, Chung SC, Woods SD, Griffin SM, Raimes SA, Lau JT, Li AK

OBJECTIVE: The authors determined if more radical surgery with extended lymphadenectomy improves the results of gastrectomy in patients with adenocarcinoma of the gastric antrum. SUMMARY BACKGROUND DATA: The overall survival in patients with gastric cancer is disappointing. Improved survival has been reported by Japanese authors. Whether this is because of a higher number of early gastric cancers in the Japanese series, different biologic behavior in Asians, or the adoption of radical surgery with lymphadenectomy remains unclear. METHODS: R1 subtotal gastrectomy with omentectomy and R3 total gastrectomy (omentectomy, splenectomy, distal pancreatectomy, lymphatic clearance of the celiac axis, and skeletonization of vessels in the porta hepatis) were evaluated in a prospective, randomized comparison. RESULTS: Fifty-five patients were randomized–25 to the R1 group and 30 to the R3 group. The two groups were comparable for age, sex, tumor size, TNM stage, and length of follow-up. The R3 group had a longer operating time (140 vs. 260 min; p < 0.05), a greater transfusion requirement (0 vs. 2 units, p < 0.05) and a longer hospital stay (8 vs. 16 days; p < 0.05) (medians; Mann-Whitney U test). The only postoperative death was in the R3 group and was caused by intra-abdominal sepsis. Fourteen patients in the R3 group developed left subphrenic abscesses. There were no major complications in the R1 group. Overall survival was significantly better in the R1 group (median survival estimated by Kaplan-Meier method, 1511 vs. 922 days, p < 0.05, log-rank test). CONCLUSIONS: R3 total gastrectomy can be performed with a low mortality, but it has a high morbidity because of intra-abdominal sepsis. The data do not support the routine use of R3 total gastrectomy for treatment of patients with antral cancer.

PMID: 8053740 [PubMed - indexed for MEDLINE]

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Glutamine-supplemented total parenteral nutrition enhances T-lymphocyte response in surgical patients undergoing colorectal resection.

Ann Surg. 1994 Aug;220(2):212-21

Authors: O’Riordain MG, Fearon KC, Ross JA, Rogers P, Falconer JS, Bartolo DC, Garden OJ, Carter DC

OBJECTIVE: The authors determined the effect of glutamine-supplementation of TPN on postoperative peripheral blood T-cell response and proinflammatory cytokine production in patients undergoing colorectal resection. SUMMARY BACKGROUND DATA: Several vital tissues, including the immune system, are very dependent on glutamine; however, this amino acid, which may be essential in conditions of stress, only now is becoming formulated suitably for incorporation into TPN. The effects of such supplementation on the immune function of stressed surgical patients is unknown. METHODS: Patients (n = 20) were randomized to receive conventional TPN (0.2 g nitrogen/kg/d) or an isonitrogenous/isocaloric regimen with 0.18 g of glutamine/kg/d from days 1 to 6 postoperatively. T-cell DNA synthesis and interleukin (IL)-2 production and peripheral blood mononuclear cell IL-6 and tumor necrosis factor (TNF) production were measured in vitro preoperatively and on days 1 and 6 postoperatively. RESULTS: T-cell DNA synthesis after 5 days of TPN was increased compared with preoperative values in the glutamine-supplemented group (median preoperative tritiated thymidine uptake: 78.3 x 10(3) cpm, day 6: 95.0 x 10(3) cpm, p < 0.05). There was no such increase in the control TPN group (preoperative: 89.0 x 10(3) cpm, day 6: 69.4 x 10(3) cpm, p > 0.05). Glutamine supplementation did not influence IL-2 production or the production of TNF or IL-6. CONCLUSIONS: Glutamine supplementation may be a method of enhancing T-cell function in the surgical patient receiving TPN.

PMID: 8053744 [PubMed - indexed for MEDLINE]

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Evaluation of preoperative radiation therapy in operable colorectal cancer.

Ann Surg. 1994 Nov;220(5):668-75

Authors: Sause WT, Pajak TF, Noyes RD, Dobelbower R, Fischbach J, Doggett S, Mohiuddin M

MATERIALS AND METHODS: Patients with operable colorectal cancer in the ascending colon, descending colon, and rectum were randomized to 500 cGy before definitive surgery. Patients with stage A and B1 lesions received no further treatment. All patients with stage B2, B3, C1, C2, and C3 received a minimum of 4500 cGy postoperatively. RESULTS: Three hundred fifty-three patients were registered for the study. Three hundred one patients were available for analyses. Follow-up was a minimum of 5 years on all study patients. The majority of patients had rectal cancer. Complications of treatment were acceptable. Two hundred thirty-one patients had stage B2, B3, C1, C2, or C3 tumors. Estimated 5-year rates for no preoperative therapy versus preoperative therapy were as follows: local recurrence 29% versus 26%; metastasis 41% versus 43%; and survival 54% versus 54%. No statistical benefit was observed for preoperative treatment. CONCLUSIONS: In a prospective randomized trial designed to test the value of low-dose preoperative irradiation followed by surgery and postoperative irradiation, the authors were unable to observe any benefit to low-dose preoperative therapy in patients with unfavorable stages.

PMID: 7979616 [PubMed - indexed for MEDLINE]

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A randomized trial for the study of the elective surgical treatment of portal hypertension in mansonic schistosomiasis.

Ann Surg. 1986 Aug;204(2):148-53

Authors: da Silva LC, Strauss E, Gayotto LC, Mies S, Macedo AL, da Silva AT, Silva EF, Lacet CM, Antonelli RH, Fermanian J

From 1977 to 1983, 94 patients with esophageal varices and gastrointestinal bleeding secondary to mansonic schistosomiasis were entered into a prospective randomized trial comparing the three operations mainly used in Brazil: esophagogastric devascularization associated with splenectomy (EGDS, 32 patients), classical splenorenal shunt (SRS, 32 patients), and distal splenorenal shunt (DSRS, 30 patients). The randomization was interrupted because of a significant incidence of portosystemic encephalopathy (PSE) in the SRS group (26%), as compared to the DSRS (7%) and EGDS (0%) groups. The rate of rebleeding was the same in the three groups, but the rate of failure, as defined by the presence of technical problems, postoperative complications, or death, was significantly higher in the SRS group. This 2-year follow-up shows that SRS should be abandoned in hepatosplenic schistosomiasis and that a comparison between DSRS and EGDS with a longer follow-up is urgently needed.

PMID: 3090954 [PubMed - indexed for MEDLINE]

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Distal splenorenal shunt versus endoscopic sclerotherapy for long-term management of variceal bleeding. Preliminary report of a prospective, randomized trial.

Ann Surg. 1986 May;203(5):454-62

Authors: Warren WD, Henderson JM, Millikan WJ, Galambos JT, Brooks WS, Riepe SP, Salam AA, Kutner MH

This paper reports the preliminary results of a prospective randomized trial comparing endoscopic variceal sclerosis and distal splenorenal shunt (DSRS) in the management of patients with cirrhosis and variceal bleeding. Seventy-one patients have been entered; 36 have received sclerosis and 35 DSRS. Randomization of the study population was stratified on Child’s A/B (56%) and Child’s C (44%). Sixty-one per cent had alcoholic and 39% non-alcoholic cirrhosis. No patients have been lost to follow-up, which currently stands at a median of 26 months. Rebleeding occurred significantly (p less than 0.05) more frequently in patients in the sclerosis group (19 of 36: 53%) compared to DSRS (1 of 35: 3%), but only 11 of 36 (31%) were not controlled by further sclerosis and failed that therapy. Patients in whom sclerosis failed underwent surgery. Survival was significantly (p less than 0.01) improved in the sclerosis group (+ surgery in 31%), with an 84% 2-year survival compared to a 59% 2-year survival in the DSRS group. Portal perfusion was significantly (p less than 0.05) better maintained in the sclerosis (95%) compared to the DSRS (53%) group. Galactose elimination capacity improved significantly (p less than 0.05) in 21 patients successfully managed by sclerosis at 1 year and was significantly (p less than 0.01) better maintained in the sclerosis compared to DSRS group. The authors conclude that endoscopic sclerosis: has a higher rebleeding rate than DSRS, with one third of patients failing therapy from rebleeding; allows significant improvement in liver function when successful; and gives significantly improved survival in the management of variceal bleeding when backed up by surgical therapy for patients with uncontrolled rebleeding.

PMID: 3486641 [PubMed - indexed for MEDLINE]

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The comparative influence of prophylactic antibiotics on the prothrombin response to warfarin in the postoperative prosthetic cardiac valve patient. Cefamandole, cefazolin, vancomycin.

Ann Surg. 1987 Aug;206(2):155-61

Authors: Angaran DM, Dias VC, Arom KV, Northrup WF, Kersten TG, Lindsay WG, Nicoloff DM

A prospective randomized trial was conducted comparing the effect of three antibiotics: cefamandole (CM), cefazolin (CZ), and vancomycin (V), used as prophylaxis for prosthetic valve surgery, on the prothrombin (PT) response to warfarin (W) on the third day of anticoagulant therapy. Twenty patients, with normal preoperative PTs, were randomized to each antibiotic. Their PTs were not significantly different at 2 hours after operation and the morning before W was begun. The three groups received similar W doses for 2 days, and the PT, as percentage of activity, on the morning of the third day demonstrated that V (51 +/- 18%) was significantly greater (p less than 0.005) than CM (29 +/- 14%) or CZ (38 +/- 18%). CM had a significantly greater percentage of change in PT (64 +/- 14%, p less than 0.0001) from the first to third day than either CZ (51.1 +/- 18%) or V (44.6 +/- 19%). CM also had a greater number of patients (6) with PTs greater than or equal to 30 seconds on day 3 than either CZ (1) or V (1). The antibiotic influence on the PT response to W in this study is ranked as CM greater than CZ greater than V.

PMID: 3300580 [PubMed - indexed for MEDLINE]

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Surgically treated gangrenous or perforated appendicitis. A comparison of aztreonam and clindamycin versus gentamicin and clindamycin.

Ann Surg. 1987 Feb;205(2):133-7

Authors: Berne TV, Yellin AE, Appleman MD, Gill MA, Chenella FC, Heseltine PN

A randomized, double-blinded, controlled clinical study of 84 patients with surgically treated gangrenous or perforated appendicitis was done to compare the efficacy of the combination of aztreonam, the first monobactam antibiotic, with gentamicin when either was combined with clindamycin. Fifty-six patients who were treated with aztreonam and clindamycin (A/C) and 28 patients who were treated with gentamicin and clindamycin (G/C) fulfilled criteria for evaluation. A matched historic control group of 56 G/C patients was also included for comparison. All measures of outcome, including days of fever, hospitalization, antibiotic therapy, and the incidence of antibiotic failures, were similar. It was concluded that aztreonam was as effective as gentamicin in this study and may offer some advantages with regard to toxicity and serum drug level monitoring.

PMID: 3545106 [PubMed - indexed for MEDLINE]

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A prospective randomized trial of regional versus systemic continuous 5-fluorodeoxyuridine chemotherapy in the treatment of colorectal liver metastases.

Ann Surg. 1987 Dec;206(6):685-93

Authors: Chang AE, Schneider PD, Sugarbaker PH, Simpson C, Culnane M, Steinberg SM

Sixty-four patients were entered into a randomized trial that evaluated intra-arterial (I.A.) versus intravenous (I.V.) 5-fluorodeoxyuridine (FUDR) for colorectal liver metastases. There was a significant improved response rate for I.A. (62%) compared with I.V. (17%) treatment (p less than 0.003). However, the improved response rate for patients in whom I.A. therapy was used did not translate to a significantly improved survival rate. The 2-year actuarial survival rates for the groups for which I.A. and I.V. therapy was used were 22% and 15% respectively, with the survival curves not differing significantly (p = 0.27). These results may have been due to the inclusion of patients with tumor in draining hepatic lymph nodes. The presence of tumor in hepatic lymph nodes was associated with a poorer prognosis. Analysis of a subgroup of patients with negative hepatic lymph nodes suggested an improved actuarial survival rate in patients for whom I.A. versus I.V. therapy was used (p less than 0.03). The toxicity of I.A. FUDR was considerable, and side effects included chemical hepatitis (79%), biliary sclerosis (21%), peptic ulcers (17%), and gastritis/duodenitis (21%). The only major effect of toxicity of I.V. FUDR was severe diarrhea (59%). Regional I.A. FUDR allowed more drug delivery to liver tumors, which resulted in increased tumor responses when compared with use of systemic therapy. However, the small gain in survival seen in a select subgroup of patients with negative hepatic nodes appeared to be offset by the toxicity of I.A. FUDR.

PMID: 2961314 [PubMed - indexed for MEDLINE]

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Effect of optimization of hemodynamics on fibrinolytic activity and antithrombotic efficacy of external pneumatic calf compression.

Ann Surg. 1987 Nov;206(5):636-41

Authors: Salzman EW, McManama GP, Shapiro AH, Robertson LK, Donovan AS, Blume HW, Sweeney J, Kamm RD, Johnson MC, Black PM

External pneumatic calf compression is effective but imperfect for antithrombotic prophylaxis in surgical patients. In preliminary studies, sequential filling of multisegmented leggings with graded pressure decreasing from ankle to knee increased venous flow velocity and wall shear stress, decreased residual venous volume, and enhanced postoperative fibrinolysis more than uniform compression. To determine if improved hemodynamics also increased antithrombotic activity, we performed a prospective randomized trial in neurosurgical patients comparing sequential application of graded pressure with uniform pressure applied to either a segmented bladder or to a single bladder. Deep vein thrombosis was diagnosed by leg scanning and impedance plethysmography and confirmed by phlebography. Venous thrombosis developed in 3 of 45 patients with graded-sequential filling, 6 of 50 with uniform compression-multiple compartments, and 3 of 41 with uniform pressure single bladder (differences not significant). These results suggest either that uniform compression offers all that can be expected of external pneumatic calf compression in prevention of venous thrombosis, or that even if a study with greater statistical power showed graded-sequential filling to be superior, the benefit/cost ratio of the more complex latter system is not likely to be large.

PMID: 3314750 [PubMed - indexed for MEDLINE]

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Efficacy of cefazolin, cefamandole, and gentamicin as prophylactic agents in cardiac surgery. Results of a prospective, randomized, double-blind trial in 1030 patients.

Ann Surg. 1987 Dec;206(6):791-7

Authors: Kaiser AB, Petracek MR, Lea JW, Kernodle DS, Roach AC, Alford WC, Burrus GR, Glassford DM, Thomas CS, Stoney WS

In an effort to develop an improved regimen of antibiotic prophylaxis in cardiac surgery, 1030 patients who were to have elective cardiothoracic surgery involving a median sternotomy were selected at random to receive cefamandole or cefazolin, with or without gentamicin, in a prospective double-blind study. Cefazolin was significantly less effective than cefamandole at both the sternal (1.8% vs. 0.4%, respectively, p less than 0.05) and donor sites (1.3% vs. 0%, respectively, p less than 0.02). Seven Staphylococcus aureus infections occurred among cefazolin recipients as compared with no such infections among the patients receiving cefamandole (p less than 0.01). All five wound infections yielding fungi or gentamicin-resistant gram-negative rods occurred in patients who had received gentamicin as a second prophylactic agent. These data suggest that gentamicin has no role as a prophylactic antibiotic in cardiac surgery and that, compared with cefamandole, cefazolin offers unreliable prophylaxis against deep infection at both the sternal and donor sites.

PMID: 3689015 [PubMed - indexed for MEDLINE]

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Proximal gastric vagotomy. The preferred operation for perforations in acute duodenal ulcer.

Ann Surg. 1988 Aug;208(2):169-74

Authors: Boey J, Branicki FJ, Alagaratnam TT, Fok PJ, Choi S, Poon A, Wong J

Simple closure, the conventional operation for perforated acute duodenal ulcers, is associated with symptomatic relapse in a large proportion of patients. In order to assess the role of immediate definitive surgery, 78 fit patients with perforated acute ulcers were prospectively randomized to undergo either closure alone or proximal gastric vagotomy with closure (PGV). Patients taking potentially ulcerogenic drugs or who had severe stress were excluded from the study. Both groups were comparable with respect to age, sex, general medical health, duration of perforation, length of ulcer history, and presence of duodenal scarring. There was no hospital mortality. Minor complications occurred in 7.3% after closure and 10.8% after PGV. At 3 years follow-up, the cumulative recurrence rates were 36.6% and 10.6% after closure and PGV, respectively (p = 0.001). Eighty-five per cent of recurrences after closure were symptomatic, and half of them required reoperation. Duodenal scarring itself did not appear to influence the outcome after closure. PGV was not associated with dumping, diarrhea or other unwanted side effects. Although less than that in chronic ulcers, there is a substantial risk of symptomatic relapse after closure of perforated acute duodenal ulcers. With judicious patient selection, PGV effectively reduces this risk without incurring disabling side effects associated with other ulcer operations.

PMID: 3401061 [PubMed - indexed for MEDLINE]

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Submaximal exercise during intravenous hyperalimentation of depleted subjects.

Ann Surg. 1988 Mar;207(3):297-304

Authors: Fong Y, Hesse DG, Tracey KJ, Albert JD, Legaspi A, Brennan MF, Lowry SF

The peripheral nitrogen wasting and loss of functional capacity caused by the malnutrition of disease and the immobilization of hospitalization may not be readily reversed by refeeding alone. In order to examine submaximal exercise as an adjunctive anabolic stimulus to intravenous refeeding (IVF) in depleted subjects, 14 volunteers were studied in the postabsorptive (PA) state, after 10 days of total starvation, and again after 10 days of nutritional repletion with I.V. feedings. The subjects were randomized to one group that received IVF alone and one group that performed 1 hour of submaximal (51% of VO2max) stationary bicycle exercise daily during IVF. The exercised group was not significantly different from the nonexercised group in urinary nitrogen balance, resting energy expenditure, extremity amino acid flux, or maximal oxygen consumption. Acute exercise did not induce significant derangements in electrolytes or counter-regulatory hormone concentrations. Ten days of submaximal exercise does not appear to be detrimental in this population recovering from moderate hospitalized malnutrition, but additional anabolic stimulae may be needed for improvements in protein accrual or functional capacity.

PMID: 3125800 [PubMed - indexed for MEDLINE]

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Artificial dermis for major burns. A multi-center randomized clinical trial.

Ann Surg. 1988 Sep;208(3):313-20

Authors: Heimbach D, Luterman A, Burke J, Cram A, Herndon D, Hunt J, Jordan M, McManus W, Solem L, Warden G

This communication presents an 11-center prospective randomized trial using the artificial dermis invented by Burke and Yannas. Patients with life-threatening burns who underwent primary excision and grafting within 7 days of injury had comparable sites randomized to receive either the artificial dermis (study site) or the investigator’s usual skin grafting material (control site). Control materials were autograft, allograft, xenograft, or a synthetic dressing. Epidermal grafts were applied to the study site during a second operation, and surviving patients were followed for 1 year after grafting. One hundred thirty-nine sites on 106 patients were studied. Mean burn size was 46.5 +/- 15% mean total body surface (TBSA). Overall mortality was 13%, and mean hospital stay was 68 +/- 45 days. Median artificial dermis take was 80% compared with 95% for all comparative sites, but the take was equivalent to that of all nonautograft control materials. Results with the artificial dermis improved slightly as the investigators became more familiar with the material. Donor site thickness for the study site averaged .006” +/- .002” compared to .013” +/- .018” for control (p less than .0001) and the epidermal donor site healed an average of 4 days sooner (10 +/- 6 vs. 14 +/- 8 days) (p less than .0001). As the wounds matured during the first year, both patients and surgeons felt that both sites became more comparable in appearance and function. At the completion of the study, there was less hypertrophic scarring of the artificial dermis, and more patients preferred the artificial dermis to the control graft. Artificial dermis with an epidermal graft provides a permanent cover that is at least as satisfactory as currently available skin grafting techniques, and uses donor grafts that are thinner and donor sites that heal faster.

PMID: 3048216 [PubMed - indexed for MEDLINE]

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Immune and metabolic effects of arginine in the surgical patient.

Ann Surg. 1988 Oct;208(4):512-23

Authors: Daly JM, Reynolds J, Thom A, Kinsley L, Dietrick-Gallagher M, Shou J, Ruggieri B

Arginine enhances immune function and promotes nitrogen retention in animal models, but its immunomodulatory effects in surgical patients are unknown. This randomized, prospective trial evaluated the immune and metabolic effects of supplemental L-arginine (25 g/day, n = 16) or isonitrogenous L-glycine (43 g/day, n = 14) in 30 cancer patients undergoing major operation. Two groups of patients received either arginine or glycine for 7 days after surgery as a supplement to a graduated enteral diet. Nitrogen balance was measured daily, and immune parameters were determined both before and after surgery, on Days 1, 4, and 7. The T-lymphocyte response to concanavalin A (con A) and PHA and dual marker phenotype analysis of lymphocyte (CD2, CD4, CD4/DR, CD8, CD8/DR) and macrophage (M3/DR) subsets were determined. Mean age, degree of preoperative weight loss, disease stage, number of perioperative transfusions, and calorie and nitrogen intake were similar for the groups studied. Mean daily nitrogen balance (-2.3 g/day in the arginine group vs. -3.9 g/day in the glycine group) was not significantly different between the two groups, but positive mean nitrogen balance was achieved only in the arginine group between Days 5 and 7 after surgery. Supplemental arginine significantly enhanced the mean T-lymphocyte response (stimulation index) to con A from 45 +/- 26 on postoperative Day 1 to 72 +/- 47 and 87 +/- 49 on postoperative Days 4 and 7, compared with the values of 29 +/- 15, 27 +/- 20, and 33 +/- 34 in the glycine group at the same time points, respectively. Supplemental arginine increased mean CD4 phenotype (% T-cells) on postoperative Days 1 and 7 from 25 +/- 9 to 43 +/- 14, compared with the values of 30 +/- 14 and 29 +/- 13 in the glycine group (p less than 0.05). The beneficial effect of arginine on the immune system appeared distinct from its more moderate effect on nitrogen metabolism. As a nutrient substrate, arginine was nontoxic, and may benefit surgical patients who are at increased risk of infection.

PMID: 3140744 [PubMed - indexed for MEDLINE]

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Preoperative radiotherapy as adjuvant treatment in rectal cancer. Final results of a randomized study of the European Organization for Research and Treatment of Cancer (EORTC).

Ann Surg. 1988 Nov;208(5):606-14

Authors: Gérard A, Buyse M, Nordlinger B, Loygue J, Pène F, Kempf P, Bosset JF, Gignoux M, Arnaud JP, Desaive C

A randomized clinical trial was conducted by the European Organization for Research and Treatment for Cancer (EORTC) Gastrointestinal Cancer Cooperative Group to study the effectiveness of irradiation therapy administered in a dosage of 34.5 Gy, divided into 15 daily doses of 2.3 Gy each before radical surgery for rectal cancer (T2, T3, T4, NX, MO). Four hundred sixty-six patients were entered in the clinical trial between June 1976 and September 1981. Tolerance and side effects of preoperative irradiation were acceptable. The overall 5-year survival rates were similar in both groups. When considering only the 341 patients treated by surgery with a curative aim, the 5-year survival rates were 59.1% and 69.1% in the control group and in the combined modality group, respectively (p = 0.08). The local recurrence rates at 5 years were 30% and 15% in the control group and the adjuvant radiotherapy group, respectively (p = 0.003). Although this study did not show preoperative radiotherapy to have a statistically significant benefit on overall survival, it does have a clear effect on local control of rectal cancer. Therefore, before performing radical surgery, this adjuvant therapy should be administered to patients who have locally extended rectal cancer.

PMID: 3056288 [PubMed - indexed for MEDLINE]

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Catheter infection. A comparison of two catheter maintenance techniques.

Ann Surg. 1988 Nov;208(5):651-3

Authors: Snyder RH, Archer FJ, Endy T, Allen TW, Condon B, Kaiser J, Whatmore D, Harrington G, McDermott CJ

Incidence of catheter-related infections was studied using two techniques: changing catheters over a guide-wire or placing a new catheter at a new site every 3 days. Patients were randomized into two groups: Group 1 (new site) and Group 2 (guide-wire). Of the 105 catheterization sites (20 arterial and 85 central lines) in patients of Group 1, none were considered infected (i.e., having 15 or more colonies at the time of semi-quantitative microbiology analysis and clinical signs of infection at the catheter site). Of the 274 catheterization sites (56 arterial and 218 central) of patients of Group 2, eight (2.9%) were infected (chi 2 = 1.89, p greater than 0.05). Colonization (15 or more cultures without clinical signs of infection) occurred in three of 105 (2.9%) and in four of 274 (1.5%) of the catheterization sites of Groups 1 and 2, respectively (chi 2 = 0.23, p greater than 0.05). Study results indicate no significant difference in infection or colonization rates between the two methods of catheter replacement.

PMID: 3190292 [PubMed - indexed for MEDLINE]

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Antibiotic prophylaxis in acute nonperforated appendicitis. The Danish Multicenter Study Group III.

Ann Surg. 1989 Mar;209(3):307-11

Authors: Bauer T, Vennits B, Holm B, Hahn-Pedersen J, Lysen D, Galatius H, Kristensen ES, Graversen P, Wilhelmsen F, Skjoldborg H

In a prospective, block-randomized, multicenter study, the safety and efficacy of cefoxitin in preoperative prophylaxis were studied. 1735 patients undergoing appendectomy were evaluable, and half of these patients received 2 g of cefoxitin before undergoing operation. The patients were divided into three groups: patients with a normal appendix, patients with an acutely inflamed appendix, and patients with a gangrenous appendix. The study showed for each group a significant reduction of the incidence of wound infection in patients receiving prophylaxis. However, intra-abdominal abscess formation was not influenced by preoperative antibiotic prophylaxis. Consequently, routine preoperative prophylaxis is recommended before appendectomy.

PMID: 2647050 [PubMed - indexed for MEDLINE]

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The influence of fibronectin administration on the incidence of sepsis and septic mortality in severely injured patients. The Medical College of Georgia Fibronectin Research Group.

Ann Surg. 1989 Sep;210(3):297-306; discussion 306-7

Authors: Mansberger AR, Doran JE, Treat R, Hawkins M, May JR, Callaway BD, Horowitz M, Horowitz B, Shulman R

Eighty-five trauma patients between the ages of 18 and 55, with American College of Surgeon’s (ACOS) trauma scores greater than or equal to 7 were entered into a double-blind, randomized, placebo-controlled study to assess the efficacy of prophylactic fibronectin (Fn) administration on clinical course, sepsis development, and septic mortality. Patients were randomized on admission to receive purified human virus-inactivated Fn or placebo control (human serum albumin, HSA). Fn or HSA was administered on a daily basis if and when the patient was Fn deficient (less than 75% normal). When a Fn deficiency was not evident, the patient received saline. Seventy one patients developed Fn deficiencies during their initial clinical course: 36 received Fn, 35 received HSA. Fourteen patients did not develop a Fn deficiency after trauma and thus received only saline. Analysis of admission data demonstrated no significant differences between the three groups with respect to extent of injury (injury severity score, ACOS trauma score) or physiologic assessments of organ function (serum creatinine, bilirubin, lactic acid). On day 1 after trauma, Fn levels were shown to correlate with other plasma proteins and cellular components (range of r values, 0.24 to 0.75; all p less than 0.05), but not with organ function parameters. Eighteen of 85 patients became septic as judged by clinical criteria. Ten of these patients had received Fn (10 of 36), five had received HSA (5 of 35), and three had received only saline (3 of 14) before the development of sepsis (differences not significant). When septic, nine of 17 patients developed Fn deficiencies. Six patients received Fn while septic, three received albumin, and eight received saline. Seven patients died: 5 of 6 Fn patients, 1 saline, and 1 HSA recipient. Our data suggest that exogenous Fn repletion in states of deficiency does not alter clinical course, the development of sepsis, or septic mortality.

PMID: 2505698 [PubMed - indexed for MEDLINE]

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Total parenteral nutrition and bowel rest modify the metabolic response to endotoxin in humans.

Ann Surg. 1989 Oct;210(4):449-56; discussion 456-7

Authors: Fong YM, Marano MA, Barber A, He W, Moldawer LL, Bushman ED, Coyle SM, Shires GT, Lowry SF

Intestinal mucosal atrophy, as induced by total parenteral nutrition (TPN) and/or prolonged bowel rest, is hypothesized to enhance bowel endotoxin (LPS) translocation and may alter host responses to infection. To examine the effect of TPN-induced bowel atrophy on the response to LPS, 12 healthy volunteers were randomized to receive either enteral feedings (ENT, n = 6) or seven days of TPN without oral intake (TPN, n = 6). Enteral or TPN feedings were terminated 12 hours before the study period when a constant dextrose infusion (50 mg/kg/hour) was initiated and continued throughout the subsequent study period. After placement of arterial, hepatic vein, and femoral vein catheters, metabolic parameters were determined before and for six hours after an intravenous E. coli LPS challenge (20 U/kg). Subsequent peak levels of arterial glucagon (ENT, 189 +/- 39 pg/mL; TPN, 428 +/- 48; p less than 0.01), arterial epinephrine (ENT, 236 +/- 52 pg/mL; TPN, 379 +/- 49; p less than 0.05) and hepatic venous cachectin/tumor necrosis factor (cachectin/TNF) (ENT, 250 +/- 56 pg/mL; TPN, 479 +/- 136; p less than 0.05) were significantly higher in the TPN group than in the ENT group. The extremity efflux of lactate (ENT, -16 +/- 4 micrograms/min-100cc tissue; TPN, -52 +/- 13; t = 2 hours; p less than 0.05) and of amino acids (ENT, -334 +/- 77 nmol/min-100cc tissue; TPN, -884 +/- 58; t = 4 hours; p less than 0.05) were higher in the TPN subjects after the endotoxin challenge. Circulating C-reactive Protein (CRP) levels measured 24 hours postendotoxin were also significantly higher in the TPN subjects (ENT, 1.7 +/- 0.2 mg/dL; TPN, 3.2 +/- 0.3; p less than 0.01). Hence the counter-regulatory hormone and splanchnic cytokine responses to LPS were enhanced after TPN and bowel rest. This is associated with a magnified acute-phase response, peripheral amino acid mobilization, and peripheral lactate production. Thus antecedent TPN may influence the metabolic alterations seen in infection and sepsis via both an exaggerated counter-regulatory hormone response as well as an enhanced systemic and splanchnic production of cytokines.

PMID: 2508583 [PubMed - indexed for MEDLINE]

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Misoprostol versus antacid titration for preventing stress ulcers in postoperative surgical ICU patients.

Ann Surg. 1989 Nov;210(5):590-5

Authors: Zinner MJ, Rypins EB, Martin LR, Jonasson O, Hoover EL, Swab EA, Fakouhi TD

Bleeding from gastroduodenal lesions is a potentially life-threatening complication in patients subjected to overwhelming physiologic stress. Titration of gastric contents with antacid was the first prophylactic treatment regimen proved to decrease the incidence of bleeding and remains the standard by which other methods are compared. We designed a prospective double-blind, double-placebo study comparing the effectiveness of antacid titration with fixed doses of a synthetic prostaglandin E1 analog (misoprostol) for preventing stress gastritis and bleeding. To assess the success of each treatment regimen, we did endoscopic examinations before operation, 72 hours after operation, and after the patient had completed the study. A total of 281 patients entered the study (140 misoprostol, 141 antacid). The two groups were comparable with respect to preoperative parameters and type of operation. We found no statistically significant differences between the two treatment groups concerning upper gastrointestinal tract lesions or serious adverse effects. No clinically evident upper gastrointestinal hemorrhage occurred in either group. Mean gastric pH, measured at two-hour intervals during the initial 72 hours, was maintained at 4.0 or higher in both groups. We conclude that fixed-dose misoprostol is as effective as intensive antacid titration in preventing stress ulcers and bleeding in surgical ICU patients.

PMID: 2510618 [PubMed - indexed for MEDLINE]

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Duodenum-preserving resection of the head of the pancreas in chronic pancreatitis. A prospective, randomized trial.

Ann Surg. 1995 Apr;221(4):350-8

Authors: Izbicki JR, Bloechle C, Knoefel WT, Kuechler T, Binmoeller KF, Broelsch CE

OBJECTIVE: Two techniques of duodenum-preserving resection of the head of the pancreas were compared in a prospective, randomized trial. The technical feasibility and effects on quality of life were assessed. SUMMARY BACKGROUND DATA: Drainage and resection are the principles of surgery in chronic pancreatitis. The techniques of duodenum-preserving resection of the head of the pancreas as described by Berger and Frey combine both to different degrees. The efficacy of both procedures has not been compared thus far. METHODS: Forty-two patients were allocated randomly to either Beger’s (n = 20) or Frey’s (n = 22) group. In addition to routine pancreatic diagnostic work-up, a multidimensional psychometric quality-of-life questionnaire and and a pain score were used. Assessment of endocrine and exocrine function included oral glucose tolerance test, serum concentrations of insulin, C-peptide, and HbA1c, as well as fecal chymotrypsin and pancreolauryl test. The interval between symptoms and surgery ranged from 12 months to 12 years, with a mean of 5.7 years. The mean follow-up was 1.5 years. RESULTS: There was no mortality. Overall morbidity was 14% (20% Beger, 9% Frey). Complications from adjacent organs were resolved definitively in 94% (90% Beger, 100% Frey). A decrease of 95% and 94% of the pain score after Beger’s and Frey’s procedure, respectively, and an increase of 67% of the overall quality-of-life index in both groups were observed. Endocrine and exocrine function did not differ between both groups. CONCLUSIONS: Both techniques of duodenum-preserving resection of the head of the pancreas are equally safe and effective with regard to pain relief, improvement of quality of life, and definitive control of complications affecting adjacent organs. Neither procedure leads to further deterioration of endocrine and exocrine pancreatic function.

PMID: 7726670 [PubMed - indexed for MEDLINE]

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Jejunal pouch reconstruction after total gastrectomy for cancer. A randomized controlled trial.

Ann Surg. 1995 Jul;222(1):27-35

Authors: Nakane Y, Okumura S, Akehira K, Okamura S, Boku T, Okusa T, Tanaka K, Hioki K

OBJECTIVE: The authors determined the optimum reconstruction procedure after total gastrectomy in terms of the quality of life of the patients. SUMMARY BACKGROUND DATA: Gastric replacement with various enteric reservoirs has been used to improve the postprandial symptoms and nutrition of patients after total gastrectomy. However, the effect of each is uncertain because no prospective randomized studies have been conducted. METHODS: A randomized controlled trial was conducted to compare the usefulness of the three reconstruction procedures of simple Roux-en-Y (RY; N = 10), pouch and Roux-en-Y (PR; N = 10), and pouch and interposition (PI; N = 10). In each subject, the postprandial symptoms, food intake in a single meal, body weight, serum nutritional parameters, and emptying time of the gastric substitute were evaluated. RESULTS: The PR group showed significantly greater food intake in a single meal than the RY and PI groups, and greater weight recovery than the PI group. A gastric emptying test also revealed satisfactory retention capacity and emptying time of the gastric substitute in the PR group. CONCLUSIONS: Pouch and Roux-en-Y reconstruction is the most useful of the three procedures for improving the postoperative quality of life. In patients with pouch and interposition reconstruction, the clinical assessment was quite poor, even though it is a physiologic route.

PMID: 7618964 [PubMed - indexed for MEDLINE]

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Laparoscopic cholecystectomy does not prevent the postoperative protein catabolic response in muscle.

Ann Surg. 1995 Jul;222(1):36-42

Authors: Essén P, Thorell A, McNurlan MA, Anderson S, Ljungqvist O, Wernerman J, Garlick PJ

OBJECTIVE: The authors determined the effect of laparoscopic cholecystectomy on protein synthesis in skeletal muscle. In addition to a decrease in muscle protein synthesis, after open cholecystectomy, the authors previously demonstrated a decrease in insulin sensitivity. This study on patients undergoing laparoscopic and open surgery, therefore, included simultaneous measurements of protein synthesis and insulin sensitivity. SUMMARY BACKGROUND DATA: Laparoscopy has become a routine technique for several operations because of postoperative benefits that allow rapid recovery. However, its effect on postoperative protein catabolism has not been characterized. Conventional laparotomy induces a drop in muscle protein synthesis, whereas degradation is unaffected. METHODS: Patients were randomized to laparoscopic or open cholecystectomy, and the rate of protein synthesis in skeletal muscle was determined 24 hours postoperatively by the flooding technique using L-(2H5)phenylalanine, during a hyperinsulinemic normoglycemic clamp to assess insulin sensitivity. RESULTS: The protein synthesis rate decreased by 28% (1.77 +/- 0.11%/day vs. 1.26 +/- 0.08%/day, p < 0.01) in the laparoscopic group and by 20% (1.97 +/- 0.15%/day vs. 1.57 +/- 0.15%/day, p < 0.01) in the open cholecystectomy group. In contrast, the fall in insulin sensitivity after surgery was lower with laparoscopic (22 +/- 2%) compared with open surgery (49 +/- 5%). CONCLUSIONS: Laparoscopic cholecystectomy did not avoid a substantial decline in muscle protein synthesis, despite improved insulin sensitivity. The change in the two parameters occurred independently, indicating different mechanisms controlling insulin sensitivity and muscle protein synthesis.

PMID: 7618966 [PubMed - indexed for MEDLINE]

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Open versus laparoscopic appendectomy. A prospective randomized comparison.

Ann Surg. 1995 Sep;222(3):256-61; discussion 261-2

Authors: Martin LC, Puente I, Sosa JL, Bassin A, Breslaw R, McKenney MG, Ginzburg E, Sleeman D

OBJECTIVE: The authors compare open and laparoscopic appendectomy in a randomized fashion with regard to length of operation, complications, hospital stay, and recovery time. METHODS: Adult patients (older than 14 years of age) with the diagnosis of acute appendicitis were randomized to either open or laparoscopic appendectomy over a 9-month period. All patients received preoperative antibiotics. The operative time was calculated as beginning with the incision and ending when the wound was fully closed. Patients that were converted from laparoscopic to open appendectomy were considered a separate group. Return to normal activity and work were determined by questioning during postoperative clinic, telephone, or mailed questionnaire. RESULTS: There was a total of 169 patients randomized, 88 to the open and 81 to the laparoscopic group. The groups were similar demographically. Of the 81 laparoscopic patients, 13 (16%) were converted to open. In the open group, 70 patients (79.5%) had acute appendicitis and 21 (23.9%) had perforative appendicitis. In the laparoscopic group, 62 patients (76.5%) had acute appendicitis and 10 (12.3%) had perforative appendicitis. There was no statistical difference in the return to activity or work between the laparoscopic and open groups. The operative time was significantly longer in the laparoscopic group (102.2 minutes vs. 81.7 minutes, p < 0.01). The hospital stay of 2.2 days in the laparoscopic group and 4.3 days in the open group was statistically (p = 0.007). There was no difference in the hospital stay for those with acute appendicitis (1.89 days vs. 2.61 days, p = 0.067) compared with those with a normal appendix but with pelvic inflammatory disease (1.1 days vs. 2.3 days, p = 0.11). There was a significant difference in patients with perforative appendicitis (1.5 days vs. 9.5 days, p < 0.01). The hospital cost for patients having laparoscopic appendectomy was $6077 and for an open appendectomy $7227 (p = 0.164). There were no increased complications associated with the laparoscopic technique. CONCLUSION: Laparoscopic appendectomy is comparable to open appendectomy with regard to complications, hospital stay, cost, return to activity, and return to work. There was a greater operative time involved with the laparoscopic technique. Laparoscopic appendectomy does not offer any significant benefit over the open approach for the routine patient with appendicitis.

PMID: 7677456 [PubMed - indexed for MEDLINE]

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Stimulation of muscle protein synthesis by long-term insulin infusion in severely burned patients.

Ann Surg. 1995 Sep;222(3):283-94; 294-7

Authors: Sakurai Y, Aarsland A, Herndon DN, Chinkes DL, Pierre E, Nguyen TT, Patterson BW, Wolfe RR

OBJECTIVE: To determine if long-term (7 days) infusion of insulin can ameliorate altered protein kinetics in skeletal muscle of severely burned patients and to investigate the hypothesis that changes in protein kinetics during insulin infusion are associated with an increased rate of transmembrane amino acid transport from plasma into the intracellular free amino acid pool. SUMMARY BACKGROUND DATA: In critically ill patients, vigorous nutritional support alone may often fail to entirely curtail muscle catabolism; insulin stimulates muscle protein synthesis in normal volunteers. METHODS: Nine patients with severe burns were studied once during enteral feeding alone (control period), and once after 7 days of high-dose insulin. The order of treatment with insulin was randomized. Data were derived from a model based on a primed-continuous infusion of L-[15N]phenylalanine, sampling of blood from the femoral artery and vein, and biopsies of the vastus lateralis muscle. RESULTS: Net leg muscle protein balance was significantly (p < 0.05) negative during the control period. Exogenous insulin eliminated this negative balance by stimulating protein synthesis approximately 350% (p < 0.01). This was made possible in part by a sixfold increase in the inward transport of amino acids from blood (p < 0.01). There was also a significant increase in leg muscle protein breakdown. The new rates of synthesis, breakdown, and inward transport during insulin were in balance, such that there was no difference in the intracellular phenylalanine concentration from the control period. The fractional synthetic rate of protein in the wound was also stimulated by insulin by approximately 50%, but the response was variable and did not reach significance. CONCLUSIONS: Exogenous insulin may be useful in promoting muscle protein synthesis in severely catabolic patients.

PMID: 7677459 [PubMed - indexed for MEDLINE]

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A prospective randomized trial of pancreaticogastrostomy versus pancreaticojejunostomy after pancreaticoduodenectomy.

Ann Surg. 1995 Oct;222(4):580-8; discussion 588-92

Authors: Yeo CJ, Cameron JL, Maher MM, Sauter PK, Zahurak ML, Talamini MA, Lillemoe KD, Pitt HA

OBJECTIVE: The authors hypothesized that pancreaticogastrostomy is safer than pancreaticojejunostomy after pancreaticoduodenectomy and less likely to be associated with a postoperative pancreatic fistula. SUMMARY BACKGROUND DATA: Pancreatic fistula is a leading cause of morbidity and mortality after pancreaticoduodenectomy, occurring in 10% to 20% of patients. Nonrandomized reports have suggested that pancreaticogastrostomy is less likely than pancreaticojejunostomy to be associated with postoperative complications. METHODS: Between May 1993 and January 1995, the findings for 145 patients were analyzed in this prospective trial at The Johns Hopkins Hospital. After giving their appropriate preoperative informed consent, patients were randomly assigned to pancreaticogastrostomy or pancreaticojejunostomy after completion of the pancreaticoduodenal resection. All pancreatic anastomoses were performed in two layers without pancreatic duct stents and with closed suction drainage. Pancreatic fistula was defined as drainage of greater than 50 mL of amylase-rich fluid on or after postoperative day 10. RESULTS: The pancreaticogastrostomy (n = 73) and pancreaticojejunostomy (n = 72) groups were comparable with regard to multiple parameters, including demographics, medical history, preoperative laboratory values, and intraoperative factors, such as operative time, blood transfusions, pancreatic texture, length of pancreatic remnant mobilized, and pancreatic duct diameter. The overall incidence of pancreatic fistula after pancreaticoduodenectomy was 11.7% (17/145). The incidence of pancreatic fistula was similar for the pancreaticogastrostomy (12.3%) and pancreaticojejunostomy (11.1%) groups. Pancreatic fistula was associated with a significant prolongation of postoperative hospital stay (36 +/- 5 vs. 15 +/- 1 days) (p < 0.001). Factors significantly increasing the risk of pancreatic fistula by univariate logistic regression analysis included ampullary or duodenal disease, soft pancreatic texture, longer operative time, greater intraoperative red blood cell transfusions, and lower surgical volume (p < 0.05). A multivariate logistic regression analysis revealed the factors most highly associated with pancreatic fistula to be lower surgical volume and ampullary or duodenal disease in the resected specimen. CONCLUSIONS: Pancreatic fistula is a common complication after pancreaticoduodenectomy, with an incidence most strongly associated with surgical volume and underlying disease. These data do not support the hypothesis that pancreaticogastrostomy is safer than pancreaticojejunostomy or is associated with a lower incidence of pancreatic fistula.

PMID: 7574936 [PubMed - indexed for MEDLINE]

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The delayed hypersensitivity response and host resistance in surgical patients. 20 years later.

Ann Surg. 1995 Oct;222(4):534-46; discussion 546-8

Authors: Christou NV, Meakins JL, Gordon J, Yee J, Hassan-Zahraee M, Nohr CW, Shizgal HM, MacLean LD

OBJECTIVE: A 20-year follow-up was conducted on research into the implications of a lack of a delayed-type hypersensitivity (DTH) skin test response among surgical patients. SUMMARY BACKGROUND DATA: The authors’ original report showed that a failed DTH response was associated with increased hospital mortality, but the role of specific and nonspecific host defense elements, comorbid factors, nutritional supplementation, and the mechanism for anergy in this adverse outcome was unknown. METHODS: A data base of 4292 patients was analyzed and reported on individual studies designed to answer some of the above questions. RESULTS: Prospective studies showed a strong association between the DTH response and mortality: reactive patients, 2.9% (75/2576); anergic patients, 20.9% (239/1142, chi square = 265, p < 0.0000001). Antibody response to protein antigens was reduced in anergic patients. Antibody response to polysaccharide antigens was normal in all patients. The hallmark of anergy is a lack of T cells in the skin, as measured by mRNA signal (CD3) for T cells. The nonspecific component of host defense, as measured by circulating and exudate polymorphonuclear cell function, showed no statistically significant difference between elective reactive and elective anergic patients. Notwithstanding some mild malnutrition in anergic patients, parental nutrition failed to correct the DTH response or many of the cellular immune functions measured. CONCLUSIONS: Over the last 5 years, because of a reduction in overall patient mortality, the contribution of a reduced DTH response to septic related mortality has lost statistical significance in elective surgical patients. A reduced DTH response maintains its strong association to sepsis-related mortality in intensive care/trauma patients, and this is the group on which future research efforts should be concentrated.

PMID: 7574933 [PubMed - indexed for MEDLINE]

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Repeated administration of recombinant human insulin-like growth factor-I in patients after gastric surgery. Effect on metabolic and hormonal patterns.

Ann Surg. 1995 Nov;222(5):646-53

Authors: Goeters C, Mertes N, Tacke J, Bolder U, Kuhmann M, Lawin P, Löhlein D

OBJECTIVE: The primary objective of this investigation was to evaluate the anticatabolic effects of repeated subcutaneous administration of recombinant human insulin-like growth factor-I (rhlGF-I) in patients after gastric surgery. SUMMARY BACKGROUND DATA: The anabolic and protein-sparing effects of growth hormone are primarily mediated by IGF-I. Malnutrition and catabolic states result in increasing blood levels of growth hormone and decreasing levels of IGF-I. Experimental data showed that exogenous IGF-I could attenuate or reverse catabolism. METHODS: After giving their written informed consent, 38 male and female patients undergoing gastrectomy (age 40-75 years, body mass index 17-30 kg/m2) were treated with 80 micrograms/kg body weight rhlGF-I or placebo in a prospective, randomized, double-blind study for 5 consecutive days. Patients received a standardized total parenteral nutritional regimen with 3 g/kg body weight glucose and 0.1 g/kg body weight nitrogen. Nitrogen balance and 3-methylhistidine excretion were measured daily. Hormone profiles (IGF-I, IGFBP1, IGFBP3, cortisol, insulin, glucagon, triiodothyronine [T3], levothyroxine [T4], and thyroxine-binding globulin) were taken.

PMID: 7487212 [PubMed - indexed for MEDLINE]

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Shouldice inguinal hernia repair in the male adult: the gold standard? A multicenter controlled trial in 1578 patients.

Ann Surg. 1995 Dec;222(6):719-27

Authors: Hay JM, Boudet MJ, Fingerhut A, Poucher J, Hennet H, Habib E, Veyrières M, Flamant Y

BACKGROUND: Hernia repair is the second most frequently performed operation in France and in the United States, the prevalence being 36 for every 1000 males. Lowering the recurrence rate by 1% would mean 1000 fewer operations for hernia repair per year in France. METHODS: Between 1983 and 1989, 1578 adult males with a total of 1706 nonrecurrent inguinal hernias were prospectively and randomly allotted to undergo either a Bassini’s repair, Cooper’s ligament, or Shouldice repair with polypropylene or a Shouldice repair with stainless steel for determination of which technique was associated with the lowest recurrence rate. Fifty-nine hernia repairs were withdrawn after inclusion. Of the 1647 remaining hernias, 52.2% were indirect, 25.6% were direct, and 23.2% were combined. Patients were seen every 6 months for 3 years and then every year. Median follow-up was 5 years 8 months (range, 3 months-8.5 years). RESULTS: At 8.5 years, 5.6% of hernias were lost to follow-up. Ninety-seven hernia repairs failed, 50% during the first 2 years. The actuarial recurrence rate was 7.94% at 8.5 years. The Shouldice repair (stainless steel or polypropylene) was associated with fewer recurrences (6.1%) than either the Bassini’s (8.6%) or Cooper’s ligament repair (11.2%) technique (p < 0.001). This difference remained significant even when the maximal bias test was used. Fewer recurrences (5.9%) were observed with the stainless steel wire Shouldice repair than with polypropylene version (6.5%), but the difference was not significant. CONCLUSIONS: Shouldice hernia repair provides the patient with the best chances of nonrecurrence regardless of the anatomical type of hernia. The Shouldice hernia repair should be the gold standard for inguinal hernia repair in men and serves as the basis for comparison with all other techniques, be they prosthetic or laparoscopic.

PMID: 8526578 [PubMed - indexed for MEDLINE]

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Preoperative gastric emptying. Effects of anxiety and oral carbohydrate administration.

Ann Surg. 1995 Dec;222(6):728-34

Authors: Nygren J, Thorell A, Jacobsson H, Larsson S, Schnell PO, Hylén L, Ljungqvist O

BACKGROUND: Overnight fasting is routine before elective surgery. This may not be the optimal way to prepare for surgical stress, however, because intravenous carbohydrate supplementation instead of fasting has recently been shown to reduce postoperative insulin resistance. In the current study, gastric emptying of a carbohydrate-rich drink was investigated before elective surgery and in a control situation. METHODS: Twelve patients scheduled for elective surgery were randomly given 400 mL of either a carbohydrate-rich drink (285 mOsm/kg, 12.0% carbohydrates, n = 6) or water 4 hours before being anesthetized. Gastric emptying was measured (gamma camera, 99Tcm). Each patient repeated the protocol postoperatively as a control. All values were presented as the mean +/- SEM by means of a nonparametric statistical evaluation. RESULTS: Despite the increased anxiety experienced by patients before surgery (p < 0.005), gastric emptying did not differ between the experimental and control situations. Initially, water emptied more rapidly than carbohydrate. However, after 90 minutes, the stomach was emptied regardless of the solution administered (3.2 +/- 1.1% [mean +/- SEM] remaining in the stomach in the carbohydrate group versus 2.3 +/- 1.2% remaining in the stomach in the water group). CONCLUSIONS: Preoperative anxiety does not prolong gastric emptying. The stomach had been emptied 90 minutes after ingestion of both the carbohydrate-rick drink and water, thereby indicating the possibility of allowing an intake of iso-osmolar carbohydrate-rich fluids before surgery.

PMID: 8526579 [PubMed - indexed for MEDLINE]

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Comparative assessment of cultured skin substitutes and native skin autograft for treatment of full-thickness burns.

Ann Surg. 1995 Dec;222(6):743-52

Authors: Boyce ST, Goretsky MJ, Greenhalgh DG, Kagan RJ, Rieman MT, Warden GD

OBJECTIVE: Comparison of cultured skin substitutes (CSSs) and split-thickness autograft (STAG) was performed to assess whether the requirement for autologous skin grafts may be reduced in the treatment of massive burns. SUMMARY BACKGROUND DATA: Cultured skin substitutes consisting of collagen-glycosaminoglycan substrates populated with autologous fibroblasts and keratinocytes have been demonstrated to close full-thickness skin wounds in athymic mice and to express normal skin antigens after closure of excised wounds in burn patients. METHODS: Data were collected from 17 patients between days 2 and 14 to determine incidence of exudate, incidence of regrafting, coloration, keratinization, and percentage of site covered by graft (n = 17). Outcome was evaluated on an ordinal scale (0 = worst; 10 = best) beginning at day 14, with primary analyses at 28 days (n = 10) and 1 year (n = 4) for erythema, pigmentation, epithelial blistering, surface roughness, skin suppleness, and raised scar. RESULTS: Sites treated with CSSs had increased incidence of exudate (p = 0.06) and decreased percentage of engraftment (p < 0.05) compared with STAG. Outcome parameters during the first year showed no differences in erythema, blistering, or suppleness. Pigmentation was greater, scar was less raised, but regrafting was more frequent in CSS sites than STAG. No differences in qualitative outcomes were found after 1 year, and antibodies to bovine collagen were not detected in patient sera. CONCLUSIONS: These results suggest that outcome of engrafted CSSs is not different from STAG and that increased incidence of regrafting is related to decreased percentage of initial engraftment. Increased rates of engraftment of CSSs may lead to improved outcome for closure of burn wounds, allow greater availability of materials for grafting, and reduce requirements for donor skin autograft.

PMID: 8526581 [PubMed - indexed for MEDLINE]

Meta-analysis of randomized, controlled clinical trials of antibiotic prophylaxis in biliary tract surgery.

Br J Surg. 1990 Mar;77(3):283-90

Authors: Meijer WS, Schmitz PI, Jeekel J

In this study all available clinical trials of antibiotic prophylaxis in biliary tract surgery, published from 1965 to 1988, were examined. Results of 42 randomized, controlled trials (4129 patients), in which a group of patients treated with antibiotics was compared with a group of patients not treated with antibiotics, were pooled. Wound infection rates in the control groups range from 3 to 47 per cent and are 15 per cent overall. The overall difference in infection rates is 9 per cent in favour of antibiotic treatment (95 per cent confidence interval 7-11 per cent), while the common odds ratio is 0.30 (95 per cent confidence interval 0.23-0.38). Subgroup meta-analysis showed a significant stronger protective effect in high risk patients, while the timing of wound inspection (i.e. early in hospital or late at follow-up) markedly influenced the treatment effect reported. Comparison of wound infection rates in patients treated with first generation versus second or third generation cephalosporins (11 trials, 1128 patients), as well as single-dose versus multiple-dose regimens (15 trials, 1226 patients) did not reveal any significant effect (P greater than 0.05) in each trial separately as well as in the overall comparison. The results indicate that there is evidence against further use of no-treatment controls and that the choice of treatment regimen can largely be made on the basis of cost.

PMID: 2138925 [PubMed - indexed for MEDLINE]

Laparoscopic vs open resection for patients with rectal cancer: comparison of perioperative outcomes and long-term survival.

Dis Colon Rectum. 2011 Jan;54(1):6-14

Authors: Baik SH, Gincherman M, Mutch MG, Birnbaum EH, Fleshman JW

The aim of the study is to assess the safety and oncologic feasibility of laparoscopic-assisted resection for rectal cancer vs open rectal resection as a phase II pilot study for a planned randomized control trial.

PMID: 21160307 [PubMed - indexed for MEDLINE]

Comparison of early mobilization and diet rehabilitation program with conventional care after laparoscopic colon surgery: a prospective randomized controlled trial.

Dis Colon Rectum. 2011 Jan;54(1):21-8

Authors: Lee TG, Kang SB, Kim DW, Hong S, Heo SC, Park KJ

Although laparoscopic surgery may permit earlier recovery compared with open surgery, no published randomized controlled trial has investigated the benefit of a multimodal rehabilitation program after laparoscopic colonic resection. This study aimed to evaluate the efficacy of a rehabilitation program after laparoscopic colon surgery in the context of a randomized controlled trial.

PMID: 21160309 [PubMed - indexed for MEDLINE]

No rectopexy versus rectopexy following rectal mobilization for full-thickness rectal prolapse: a randomized controlled trial.

Dis Colon Rectum. 2011 Jan;54(1):29-34

Authors: Karas JR, Uranues S, Altomare DF, Sokmen S, Krivokapic Z, Hoch J, Bartha I, Bergamaschi R,

No randomized controlled trial has compared no rectopexy with rectopexy for external full-thickness rectal prolapse.

PMID: 21160310 [PubMed - indexed for MEDLINE]

What is the risk for a permanent stoma after low anterior resection of the rectum for cancer? A six-year follow-up of a multicenter trial.

Dis Colon Rectum. 2011 Jan;54(1):41-7

Authors: Lindgren R, Hallböök O, Rutegård J, Sjödahl R, Matthiessen P

The aim of this study was to assess the risk for permanent stoma after low anterior resection of the rectum for cancer.

PMID: 21160312 [PubMed - indexed for MEDLINE]