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.
Angrisani
Luigi
L
ASL NA1-Laparoscopic and Minimally Invasive Surgical Unit, S. Giovanni Bosco Hospital and Federico II University, Piazza Vittoria 7, 80121 Naples, Italy. luigiangrisani@chururgiaobesita.it
Lorenzo
Michele
M
Borrelli
Vincenzo
V
Ciannella
Monica
M
Bassi
Uberto Andrea
UA
Scarano
Paolo
P
D000328:Adult; D016063:Blood Loss, Surgical / Q000517:prevention & control; D005260:Female; D015390:Gastric Bypass / Q000379:methods; D006488:Hemostasis, Surgical / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D017792:Surgical Stapling / Q000379:methods*