The use of fibrin sealant to prevent major complications following laparoscopic gastric bypass: results of a multicenter, randomized trial.
BACKGROUND
Published interim results have shown that fibrin sealant (Tissucol/Tisseel Baxter AG, Vienna, Austria) may be effective in preventing anastomotic leaks and internal hernias following laparoscopic Roux-en-Y gastric bypass (LRYGBP). We report the final results of a multicenter, randomized clinical trial evaluating the use of fibrin sealant in LRYGBP.


METHODS
Between January 2004 and December 2005, 340 patients aged 21-65 years with a body mass index (BMI) of 40-59 kg/m(2) undergoing LRYGBP were randomized (1:1) to two treatment groups: fibrin sealant group (applied to gastrojejunal and jejunojejunal anastomoses and over mesenteric openings), and control group (no fibrin sealant; suture of the mesenteric openings). Operative time, early and late complications, reinterventions, time to oral diet initiation, and length of stay were assessed.


RESULTS
Overall, 320 patients were included into the study: 160 in the control group and 160 in the fibrin sealant group. All patients completed follow-up assessments at 6 and 12 months, and 60.9% completed assessments at 24 months. There were no significant differences between groups with respect to demographics, operative time, oral diet initiation, hospital stay, and BMI reduction at 6, 12, and 24 months. The incidence of anastomotic leak was numerically, but not significantly, greater in the control group. The overall reintervention rate for specific early complications (<30 days) was significantly higher in the control group (p = 0.016). No deaths or conversions to open laparotomy occurred.


CONCLUSIONS
The use of fibrin sealant in laparoscopic RYGBP may be beneficial in reducing the reintervention rate for major perioperative (<30 days) complications. Larger studies are needed.
Silecchia
Gianfranco
G
Department of Surgery P. Stefanini, Policlinico Umberto I, University La Sapienza, Viale Policlinico 155, Rome, 00161, Italy. gianfranco.silecchia@uniroma1.it
Boru
Cristian Eugeniu
CE
Mouiel
Jean
J
Rossi
Marco
M
Anselmino
Marco
M
Morino
Mario
M
Toppino
Mario
M
Gaspari
Achille
A
Gentileschi
Paolo
P
Tacchino
Roberto
R
Basso
Nicola
N
D000328:Adult; D000368:Aged; D000714:Anastomosis, Surgical; D016009:Chi-Square Distribution; D005260:Female; D015718:Fibrin Tissue Adhesive / Q000627:therapeutic use*; D005602:France; D015390:Gastric Bypass / Q000379:methods*; D006801:Humans; D015994:Incidence; D007558:Italy; D010535:Laparoscopy / Q000379:methods*; D007902:Length of Stay / Q000706:statistics & numerical data; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000453:epidemiology / Q000517:prevention & control*; D011446:Prospective Studies; D012086:Reoperation; D016896:Treatment Outcome
D015718:Fibrin Tissue Adhesive