Laparoscopic adjustable gastric banding with truncal vagotomy versus laparoscopic adjustable gastric banding alone: interim results of a prospective randomized trial.

BACKGROUND: In an attempt to potentiate the effect of laparoscopic gastric banding (LGB) on weight reduction and to reduce the risk of weight regain, we added laparoscopic truncal vagotomy (TV) to adjustable LGB. We report on our early interim results of a prospective 5-year randomized clinical trial comparing patients who underwent LGB plus TV (LGBTV) with a control group who underwent LGB alone. METHODS: From December 2005 to November 2006, patients were randomly allocated to LGBTV or LGB alone. In the LGBTV group, the anterior and posterior vagus trunks were isolated and resected after preparing and encircling the esophagus at the diaphragmatic crus. In both groups, an 11-cm Lap-Band System was positioned by way of the pars flaccida. RESULTS: A total of 50 patients were entered into the study. No mortality resulted, and no conversion to laparotomy was needed. Neither group had any intra- or postoperative complications. The mean weight, body mass index, and percentage of excess weight loss were not significantly different statistically between the 2 groups at 12 or 18 months after surgery (P = NS). At 6 months of follow-up, band adjustment was not required in 10 (50%) of 20 patients with LGBTV compared with 5 (20%) of 25 patients with LGB alone (P = .034). At 12 months, 7 (35%) of 20 LGBTV patients and 2 (8%) of 25 LGB patients still did not require band adjustment (P = .024). CONCLUSION: The results of our study have shown that adding TV to LGB does not cause specific morbidity or mortality compared with LGB alone. During the first postoperative year, the addition of TV to LGB decreased the number of patients requiring band adjustments.

The use of bovine pericardial strips on linear stapler to reduce extraluminal bleeding during laparoscopic gastric bypass: prospective randomized clinical trial.

BACKGROUND: A prospective comparison was conducted of extraluminal bleeding following gastric transection with or without staple-line reinforcement by dehydrated bovine pericardium (Peri-Strips Dry--PSD) during laparoscopic Roux-en-Y gastric bypass (LRYGBP). METHODS: From January 2001 to September 2003, 98 consecutive morbidly obese patients underwent LRYGBP. Patients were randomly allocated to 2 groups according to the use (Group A, n= 50) or not (Group B, n= 48) of Peri-Strips Dry. In both groups, mortality, intra- and postoperative early and late complications, operating-time, number of hemostatic clips used, blood transfusion and any specific event directly related to the prosthetic material were prospectively evaluated. Data were expressed as mean +/- SD except as otherwise indicated. Statistical analysis was done by means of Student t-test and Fisher exact test. P-value cut off for statistical significance was set at 0.05. RESULTS: Intra- and postoperative mortality were absent. Intra-operative methylene blue test was positive in 6/48 (12.5%) of Group B patients (P<0.001). Overall laparotomic conversion was 3/98 patients (3.1%). One/48 Group B patient was converted because of unsatisfactory exposure and one for linear stapler misfire. One/50 Group A patients was converted for short gastric vessels bleeding during dissection. No patients were re-operated or transfused because of extraluminal bleeding. Mean number of clips used was significantly lower in Group A patients (5 vs 23, P<0.001). The operating-time was significantly less in Group A patients (120+/-60 vs 220+/-100 minutes, P<0.01). CONCLUSIONS: Gastric staple-lines reinforced with Peri-Strips Dry result in a significant reduction in the number of Endo-clips used and prevent bleeding. A dry operating field was obtained, and operating-time was significantly reduced. No adverse events could be related to the use PSD.