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(R)-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 Ped-Strips Dry(R). 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(R) 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.