BACKGROUND:Intra-peritoneal adhesions are frequent following abdominal surgery and are the most common cause of small bowel obstructions. A hyaluronic acid/carboxymethylcellulose (HA/CMC) film adhesion barrier has been shown to reduce adhesion formation in abdominal surgery. An HA/CMC powder formulation was developed for application during laparoscopic procedures.METHODS:This was an exploratory, prospective, randomised, single-blind, parallel-group, Phase IIIb, multicentre study conducted at 15 hospitals in France to assess the safety of HA/CMC powder versus no adhesion barrier following laparoscopic colorectal surgery. Subjects ≥18 years of age who were scheduled for colorectal laparoscopy (Mangram contamination class I‒III) within 8 weeks of selection were eligible, regardless of aetiology. Participants were randomised 1:1 to the HA/CMC powder or no adhesion barrier group using a centralised randomisation list. Patients assigned to HA/CMC powder received a single application of 1 to 10 g on adhesion-prone areas. In the no adhesion barrier group, no adhesion barrier or placebo was applied. The primary safety assessments were the incidence of adverse events, serious adverse events, and surgical site infections (SSIs) for 30 days following surgery. Between-group comparisons were made using Fisher's exact test.RESULTS:Of those randomised to the HA/CMC powder (n = 105) or no adhesion barrier (n = 104) groups, one patient in each group discontinued prior to the study end (one death in each group). Adverse events were more frequent in the HA/CMC powder group versus the no adhesion barrier group (63% vs. 39%; P <0.001), as were serious adverse events (28% vs. 11%; P <0.001). There were no statistically significant differences between the HA/CMC powder group and the no adhesion barrier group in SSIs (21% vs. 14%; P = 0.216) and serious SSIs (12% vs. 9%; P = 0.38), or in the most frequent serious SSIs of pelvic abscess (5% and 2%; significance not tested), anastomotic fistula (3% and 4%), and peritonitis (2% and 3%).CONCLUSIONS:This exploratory study found significantly higher rates of adverse events and serious adverse events in the HA/CMC powder group compared with the no adhesion barrier group in laparoscopic colorectal resection.TRIAL REGISTRATION:ClinicalTrials.gov NCT00813397. Registered 19 December 2008.
Objective: To identify the mortality risk factors of elderly patients (>= 65 years old) during major digestive surgery, as defined according to the complexity of the operationBackground: In the aging populations of developed countries, the incidence rate of major digestive surgery is currently on the rise and is associated with a high mortality rate. Consequently, validated indicators must be developed to improve elderly patients' surgical care and outcomes.Methods: We acquired data from a multicenter prospective cohort that included 3322 consecutive patients undergoing major digestive surgery across 47 different facilities. We assessed 27 pre-, intra-, and postoperative demographic and clinical variables. A multivariate analysis was used to identify the independent risk factors of mortality in elderly patients (n = 1796). Young patients were used as a control group, and the end-point was defined as 30-day postoperative mortality.Results: In the entire cohort, postoperative mortality increased significantly among patients aged 65-74 years, and an age >= 65 years was by itself an independent risk factor for mortality (odds ratio [OR], 2.21; 95% confidence interval [CI], 1.36-3.59; P = 0.001). The mortality rate among elderly patients was 10.6%. Six independent risk factors of mortality were characteristic of the elderly patients: age >= 85 years (OR, 2.62; 95% CI, 1.08-6.31; P = 0.032), emergency (OR, 3.42; 95% CI, 1.67-6.99; P = 0.001), anemia (OR, 1.80; 95% CI, 1.02-3.17; P = 0.041), white cell count > 10,000/mm(3) (OR, 1.90; 95% CI, 1.08-3.35; P = 0.024), ASA class IV (OR, 9.86; 95% CI, 1.77-54.7; P = 0.009) and a palliative cancer operation (OR, 4.03; 95% CI, 1.99-8.19; P < 0.001).Conclusion: Characterization of independent validated risk indicators for mortality in elderly patients undergoing major digestive surgery is essential and may lead to an efficient specific workup, which constitutes a necessary step to developing a dedicated score for elderly patients.
BACKGROUND: Many factors are believed to influence the mortality and morbidity after operations for adhesive small bowel obstruction (SBO).METHODS: In a multicenter prospective cohort of 286 patients operated on for adhesive postoperative SBO, we studied the in-hospital and 30-day postdischarge mortality (early mortality) and morbidity as well as long-term mortality using univariate and multivariate analysis.RESULTS: In the present cohort, with a median follow-up of 41 months and 9% patients lost to follow-up at the end of the study, the prevalence of early postoperative mortality was 3%. All deceased patients were over 75 years old with an American Society of Anesthesiologists (ASA) class >= III. The prevalence of long-term mortality was 7% with the following independent risk factors: age >75 years old (hazards ratio [HR] 6.6 [95% confidence interval [0], 2.4-18.1]), medical complications (HR 7.4 [0, 2.2-24.3]), and a mixed mechanism of obstruction (HR 4.5 [CI, 1.5-13.7]). Prevalence of medical and surgical morbidity was 8% and 6%, respectively. Independent risk factors for medical complications were ASA class >= III (odds ratio [OR] 16.8 [CI, 2.1-133.1]) and bands (OR 14.1 [Cl, 1.8-111.5]) and for the surgical complications the number of obstructive structures >= 10 (OR 8.3 [CI, 1.6-19.7]), a nonresected intestinal wall injury (OR 5.3 [CI, 1.5-18.3]), and intestinal necrosis (OR 5.6 [CI, 1.6-19.7]). Otherwise, 3 patients with "apparent" reversible ischemia developed a postoperative intestinal necrosis followed by 2 reoperations and I death.CONCLUSION: The early postoperative mortality is strongly linked with the age and the ASA class and the long-term mortality with postoperative complications. More frequent bowel resections might be suggested for patients featuring a number of obstructive structures 10 and an intestinal wall injury, especially when associated with a reversible intestinal ischemia. (C) 2008 Elsevier Inc. All rights reserved.
We report the death of a young man during a laparoscopic partial splenectomy performed with an argon plasma coagulator to remove a benign cyst. The report analyzes the very particular mechanism of a gas embolism, which caused death here. This analysis leads us to recommend a close attention on the use of argon coagulators during laparoscopy. The aim of this article is to draw surgeons' attention to the conclusions of a court-ordered expert assessment intended to elucidate the mechanisms responsible for the death of a 20-year-old man during a laparoscopic partial splenectomy performed with an argon plasma coagulator to remove a benign cyst.
Objective: The aim of the present study was to determine the cumulative incidence and the risk factors of recurrence in patients operated on for an adhesive postoperative small bowel obstruction (SBO).Summary Background Data: Postoperative intraperitoneal adhesions, or bands, resulting from any type of abdominal surgery, are the main cause of adhesive postoperative small bowel obstructions, which represent a life-long issue. Recurrences after operated adhesive postoperative SBO are a threatening potentiality for patients and a difficult problem facing any surgeon. Today the cumulative incidence and the risk factors of recurrence have been retrospectively reported but have never been prospectively evaluated in a multicenter study.Methods: From January 1997 to January 2002, we enrolled 286 patients operated on for an adhesive postoperative SBO in a prospective multicenter trial. A systematic follow-up was carried out and ended in April 2003. Studied factors for recurrent adhesive postoperative SBO were as follows: age, gender, ASA status, number and sites of previous operations, previous operation for adhesive postoperative SBO, elapsed time from the latest operation, surgical approach, number and type of obstructive structures, site and mechanism of obstruction, final operations, and postoperative surgical and medical complications. They were analyzed using Kaplan-Meier method. A Cox regression model was used to determine the independent risk factor of recurrence.Results: The median follow-up was 41 months (range, 1-75 months). The cumulative incidence of overall recurrence was 15.9%, and for surgically managed recurrence 5.8%. In multivariate analysis, the risk factors for the overall recurrences were age <40 years (hazard ratio [HR], 2.97; confidence interval [CI], 1.48-5.94), adhesion or matted adhesion (HR, 3.79; Cl, 1.84-7.78) and, for the surgically managed: adhesions or matted adhesions (HR, 3.64; Cl, 1.12-11.84), and postoperative surgical complications (HR, 5.63; Cl, 1.73-18.28).Conclusion: Operated adhesive postoperative SBO is a clinical entity with a high recurrence rate and specific risk factors of recurrences. Thus, the patients operated on for adhesive postoperative SBO may be candidates for the preventive use of anti-adhesion agents, particularly when a risk factor of recurrence is present.
OBJECTIVE:To highlight the in vivo protein markers in human peritoneal mesothelial cells according to their anatomical distribution and their interest in theories of peritoneal repair.DESIGN:Clinical laboratory study.SETTING:University Hospital, France.PATIENTS:Sampling of mesothelial cells during 8 laparotomies by impression smears.MAIN OUTCOME MEASURES:Immunochemical semiquantitative measures of proteins.RESULTS:There were uniform ratios of protein markers among the whole peritoneal mesothelial cell population, whatever their anatomical origin (liver, stomach, omentum, small bowel, and abdominal wall).CONCLUSION:This is consistent with the surrounding uninjured mesothelial cells or the exfoliated mesothelial cells, or both, having a role in postoperative peritoneal mesothelial repair.