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 underwentLRYGBP. 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.
RCT Entities:
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 obesepatients 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.
Authors: Luigi Angrisani; Pier Paolo Cutolo; Jane N Buchwald; Tim W McGlennon; Gabriella Nosso; Francesco Persico; Brunella Capaldo; Silvia Savastano Journal: Obes Surg Date: 2011-06 Impact factor: 4.129