A multicentre, randomised, controlled trial to assess the safety, ease of use, and reliability of hyaluronic acid/carboxymethylcellulose powder adhesion barrier versus no barrier in colorectal laparoscopic surgery.

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.

Short- and midterm results between laparoscopic Roux-en-Y gastric bypass and laparoscopic sleeve gastrectomy for the treatment of morbid obesity.

BACKGROUND: Laparoscopic Roux-en-Y gastric bypass (LRYGB) is one of the most widely used bariatric procedures today, and laparoscopic sleeve gastrectomy (LSG) as a single-stage procedure for the treatment of morbid obesity is becoming increasingly popular in Europe. The aim of this study was to compare short- and midterm results between LRYGB and LSG. METHODS: An observational retrospective study from a database of patients undergoing LRYGB and LSG between January 2008 and June 2011. Seventy patients (mean age 39 years) were included. Patients were followed at 6, 12, and 18 months. Operative time, length of stay, weight loss, comorbidity improvement or resolution, postoperative complications, reinterventions and mortality were evaluated. RESULTS: Thirty-six LRYGB and 34 LSG were included. Mean operative time of LSG was 106 min while LRYGB was 196 min (P < 0.001). Differences in length of stay, early and late complications, and improvement or resolution in comorbidities were not significant (P > 0.05). Eighteen months after surgery, average excess weight loss was 77.6% in LRYGB and 57.1% in LSG (P = 0.003). There was no surgery-related mortality. CONCLUSIONS: Both LRYGB and LSG are safe procedures that provide good results in weight loss and resolution of comorbidities at 18 months.

High preoperative depression, phobic anxiety, and binge eating scores and low medium-term weight loss in sleeve gastrectomy obese patients: a preliminary cohort study.

OBJECTIVE: Although depression, anxiety, and binge eating are prevalent in candidates for bariatric surgery, their impact on weight loss is unknown following sleeve gastrectomy. This study assesses the associations between weight loss and preoperative depression, anxiety, and binge eating scores in patients undergoing sleeve gastrectomy for morbid obesity. METHOD: This cohort study included 34 patients who underwent sleeve gastrectomy for morbid obesity between May 2006 and February 2010 in a French tertiary referral center. We assessed preoperative depression (using the Beck depression inventory and the SCL-90-R depression subscale), anxiety (using the Hamilton anxiety rating scale and the SCL-90-R anxiety subscales), and binge eating (using the bulimic investigatory test, Edinburgh). The primary outcome was the percentage of excess weight loss at 12 months (PEWL). RESULTS: The preoperative mean body mass index (BMI) was 55.3 kg/m2 ± 10.2 kg/m2 and 41.7 kg/m2 ± 8.7 kg/m2 at the 12-month follow-up visit. The mean PEWL was 46.8% ± 15.8%. After adjusting for the preoperative BMI, the PEWL was negatively associated with preoperative scores for depression (ß= -0.357; P < 0.05), phobic anxiety (ß = -0.340; P < 0.05), interpersonal sensitivity (ß = -0.328; P < 0.05), and binge eating (ß = -0.315; P = 0.05). Other forms of anxiety were not correlated with the PEWL. CONCLUSIONS: Higher preoperative depression, phobic anxiety, interpersonal sensitivity, and binge eating scores are associated with low postoperative weight loss in patients undergoing sleeve gastrectomy. Future studies should assess the preoperative prevalence of syndromal or subsyndromal atypical depression and its relationship to postoperative weight loss in bariatric surgery candidates.

Observations regarding 'quality of life' and 'comfort with food' after bariatric surgery: comparison between laparoscopic adjustable gastric banding and sleeve gastrectomy.

BACKGROUND: Although laparoscopic adjustable gastric banding (LAGB) and laparoscopic sleeve gastrectomy (LSG) are coexisting first-choice restrictive procedures for bariatric surgery candidates, it is possible, given their different modes of action, that these procedures have different effects on quality of life (QOL). We hypothesized that improvement of QOL and comfort with food could be better with LSG compared to LAGB. METHODS: This cohort study included 131 obese patients who had either LAGB (n = 102) or LSG (n = 29). Patients were assessed during preoperative and at 6- and 12-month postoperative visits. Five QOL dimensions were assessed using the 'Quality of Life, Obesity and Dietetics' rating scale: physical impact, psycho-social impact, impact on sex life, comfort with food and diet experience. We compared QOL evolution between LAGB and LSG using linear mixed models adjusted for gender and body mass index at each visit. RESULTS: Excess weight loss was 28.4 ± 14.7% and 34.8 ± 18.4% for LAGB and 35.7 ± 14.3% and 43.8 ± 17.8% for LSG at 6 and 12 months postoperatively, respectively. Both LAGB and LSG provided significant improvement in the physical, psycho-social, sexual and diet experience dimensions of QOL. LSG was associated with better improvement than LAGB in short-term (6-month) comfort with food. CONCLUSIONS: Our results add further evidence to the benefit of LSG and LAGB in obesity management. Within the first year of follow-up, there is no lasting difference in the comfort with food dimension between LSG and LABG.

Study of swallowing sound at the esophagogastric junction before and after fundoplication.

INTRODUCTION: Swallowing sounds can be heard in the lower esophagus by xiphoid auscultation. We hypothesize that the xiphoid sound analysis could provide information concerning the integrity of the esophagogastric junction (EGJ), i.e., superposition of the lower esophageal sphincter (LES) and the diaphragm to assess clinical diagnosis of gastroesophageal reflux disease (GERD) and results of Nissen fundoplication (NF). The aim was to evaluate the changes in sound parameters using our acoustic technique after reorganization of the EGJ after NF. METHODS: For 21 patients with GERD and hiatus hernia, two microphones were placed below the cricoid and on the xiphoid cartilages. The frequency and duration of xiphoid sounds, esophageal transit time were calculated. We defined the xiphoid sound as composed of vibration groups separated by periods >100 ms. The number of vibration groups, number of vibrations per group, and interval between groups were also calculated. RESULTS: The xiphoid sound frequency was increased after NF, and the esophageal transit time and xiphoid sound duration were significantly decreased. A significant correlation was found between xiphoid sound duration and LES-diaphragm displacement. The number of vibration groups and interval between groups were reduced after NF. CONCLUSION: The acoustic technique for swallowing revealed the effects of NF upon the dynamic profile of the EGJ. The organization of vibration groups at the EGJ suggested that the passage of the bolus was modified by hiatus hernia, i.e., dissociation between the LES and the diaphragm and regularized by NF. Concomitant acoustic and radiologic study should contribute to better understanding of sound related to EGJ structure and boli.

Emergency laparoscopic management of perforated sigmoid diverticulitis: a promising alternative to more radical procedures.

BACKGROUND: Classic emergency surgical management of complicated perforated sigmoid diverticulitis is based on the principle of a two-stage operation, with colon resection and temporary stoma (Hartmann's procedure). But the later second-stage operation can be technically difficult and can be associated with a significant morbidity rate. We argue that laparoscopy may be beneficial in such patients with peritonitis in terms of operative results and could facilitate later surgical management. STUDY DESIGN: We studied all consecutive patients with perforated sigmoid diverticulitis requiring emergency surgery between January 2000 and December 2004. RESULTS: Twenty-four patients underwent emergency laparoscopic management for perforated sigmoid diverticulitis. Nineteen patients (80%) were found to have a purulent or fecal diffuse peritonitis. No conversion and colostomy were necessary. The overall morbidity rate was 8%; 2 patients with pelvic abscesses required radiologic drainage. The median hospital stay was 12 days (range 7 to 35 days). Prophylactic sigmoid resection was performed by laparoscopy in all patients, with a conversion rate of 16%. CONCLUSIONS: Laparoscopic treatment of generalized peritonitis secondary to diverticulitis is feasible and safe and may be a promising alternative to more radical surgery in selected patients, avoiding fecal diversion and allowing a delayed elective laparoscopic sigmoid resection.

Acute diverticulitis in very young patients: a frequent surgical management.

PURPOSE: The natural history of sigmoid diverticulitis in terms of the virulence and management in young patients is an ongoing controversy. This retrospective study was designed to assess the severity and early management of acute diverticulitis according to age. METHODS: From 2000 to 2004, 284 patients were admitted for acute diverticulitis. Fifty-two patients (18 percent) were aged 50 years or younger and were divided in two groups: aged 40 years or younger (Group 1, n = 20), and patients older than aged 40 years (Group 2, n = 32). The diagnosis was confirmed by computed tomography in 49 patients (94 percent). RESULTS: Radiologic findings showed that the rate of complicated lesions (i.e., diverticular perforation and/or abscess) was significantly higher for patients younger than aged 40 years than patients older, respectively 72 and 35 percent (P = 0.02). The risk of requiring immediate surgical treatment was significantly more frequent in Group 1 than Group 2 (40 vs.13 percent; P = 0.04). There was a trend toward a higher risk of "major surgery" (i.e., Hartmann's procedure) in Group 1 than Group 2 (15 vs. 0 percent; P = 0.05). CONCLUSIONS: Diverticulitis in patients younger than aged 40 years seems to have a particularly aggressive and fulminant course and requires early surgical procedures for complications (associated abscess, colonic perforation) in 40 percent of cases. The use of "major procedure" (i.e., stoma) is more frequent in these patients.

Stapled hemorrhoidopexy versus milligan-morgan hemorrhoidectomy: a prospective, randomized, multicenter trial with 2-year postoperative follow up.

PURPOSE: The purpose of this study was to compare the outcome of stapled hemorrhoidopexy (SH group) performed using a circular stapler with that of the Milligan-Morgan technique (MM group). The goals of the study were to evaluate the efficacy and reproducibility of stapled hemorrhoidopexy and define its place among conventional techniques. METHODS: A series of 134 patients were included at 7 hospital centers. They were randomized according to a single-masked design and stratified by center (with balancing every 4 patients). Patients were clinically evaluated preoperatively and at 6 weeks, 1 year, and a minimum of 2 years after treatment. Patients completed a questionnaire before and 1 year after surgery to evaluate symptoms, function, and overall satisfaction. RESULTS: The mean follow-up period was 2.21 years +/- 0.26 (1.89-3.07). Nine patients (7%) could not be monitored at 1 or 2 years, but 4 of these 9 nevertheless filled in the 1-year questionnaire. The patients in the SH group experienced less postoperative pain/discomfort as scored by pain during bowel movement (P < 0.001), total analgesic requirement over the first 3 days (according to the World Health Organization [WHO] class II analgesics [P = 0.002]; class III [P = 0.066]), and per-patient consumption frequency of class III analgesics (P = 0.089). A clear difference in morphine requirement became evident after 24 hours (P = 0.010). Hospital stay was significantly shorter in the SH group (SH 2.2 +/- 1.2 [0; 5.0] versus MM 3.1 +/- 1.7 [1; 8.0] P < 0.001). At 1 year, no differences in the resolution of symptoms were observed between the 2 groups, and over 2 years, the overall incidence of complications was the same, specifically fecaloma (P = 0.003) in the MM group and external hemorrhoidal thrombosis (P = 0.006) in the SH group. Impaired sphincter function was observed at 1 year with no significant difference between the groups for urgency (12%), continence problems (10%), or tenesmus (3%). No patient needed a second procedure for recurrence within 2 years, although partial residual prolapse was detected in 4 SH patients (7.5%) versus 1 MM patient (1.8%) (P = 0.194). CONCLUSION: Stapled hemorrhoidopexy causes significantly less postoperative pain. The technique is reproducible and can achieve comparable outcomes as those of the MM technique as long as the well-described steps of the technique are followed. Like with conventional surgery, anorectal dysfunction can occur after stapled hemorrhoidopexy in some patients. Its effectiveness in relieving symptoms is equivalent to conventional surgery, and the number of hemorrhoidal prolapse recurrences at 2 years is not significantly different. Hemorroidopexy is applicable for treating reducible hemorrhoidal prolapse.