The Use of Bovine Pericardial Strips on Linear Stapler to Reduce Extraluminal Bleeding during Laparoscopic Gastric Bypass: Prospective Randomized Clinical Trial
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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.
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