Skip to main content
Top
Published in: Surgical Endoscopy 11/2008

01-11-2008

The use of fibrin sealant to prevent major complications following laparoscopic gastric bypass: results of a multicenter, randomized trial

Authors: Gianfranco Silecchia, Cristian Eugeniu Boru, Jean Mouiel, Marco Rossi, Marco Anselmino, Mario Morino, Mario Toppino, Achille Gaspari, Paolo Gentileschi, Roberto Tacchino, Nicola Basso

Published in: Surgical Endoscopy | Issue 11/2008

Login to get access

Abstract

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/m2 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.

Conclusion

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.
Literature
1.
go back to reference Jackson MR (2001) Fibrin sealants in surgical practice: an overview. Am J Surg 182(Suppl.2):S1–S7CrossRef Jackson MR (2001) Fibrin sealants in surgical practice: an overview. Am J Surg 182(Suppl.2):S1–S7CrossRef
2.
go back to reference Tredree R, Beierlein W, Debrix I et al (2006) Evaluating the differences between fibrin sealants: recommendations from an international advisory panel of hospital pharmacists. Eur J Hosp Pharm Sci 12:3–9 Tredree R, Beierlein W, Debrix I et al (2006) Evaluating the differences between fibrin sealants: recommendations from an international advisory panel of hospital pharmacists. Eur J Hosp Pharm Sci 12:3–9
4.
go back to reference Capussotti L, Ferrero A, Vigano L et al (2006) Bile leakage and liver resection. Arch Surg 141:690–694PubMedCrossRef Capussotti L, Ferrero A, Vigano L et al (2006) Bile leakage and liver resection. Arch Surg 141:690–694PubMedCrossRef
5.
go back to reference Sanabria AE, Morales CH, Villegas MI (2005) Laparoscopic repair for perforated peptic ulcer disease. Cochrane Database Syst Rev 4:CD004778PubMed Sanabria AE, Morales CH, Villegas MI (2005) Laparoscopic repair for perforated peptic ulcer disease. Cochrane Database Syst Rev 4:CD004778PubMed
6.
go back to reference Kawamura M, Gika M, Izumi Y et al (2005) The sealing effect of fibrin glue against alveolar air leakage evaluated up to 48 h; comparison between different methods of application. Eur J Cardiothorac Surg 28:39–42PubMedCrossRef Kawamura M, Gika M, Izumi Y et al (2005) The sealing effect of fibrin glue against alveolar air leakage evaluated up to 48 h; comparison between different methods of application. Eur J Cardiothorac Surg 28:39–42PubMedCrossRef
7.
go back to reference Tawil Bill (2006) Fibrin and its applications. In: Guelcher SA, Hollinger JO (eds) An introduction to biomaterials. CRC, Boca Raton, FL pp 105–120 Tawil Bill (2006) Fibrin and its applications. In: Guelcher SA, Hollinger JO (eds) An introduction to biomaterials. CRC, Boca Raton, FL pp 105–120
8.
go back to reference Evans AL, Morrey AF (2006) Current application of fibrin sealant in urologic surgery. Int Braz J Urol 32:131–141PubMedCrossRef Evans AL, Morrey AF (2006) Current application of fibrin sealant in urologic surgery. Int Braz J Urol 32:131–141PubMedCrossRef
9.
go back to reference Sapala JA, Wood MH, Chuhknecht MP (2004) Anastomotic leak prophylaxis using a vapour-heated fibrin sealant: Report on 738 gastric bypass patients. Obes Surg 14:35–42PubMedCrossRef Sapala JA, Wood MH, Chuhknecht MP (2004) Anastomotic leak prophylaxis using a vapour-heated fibrin sealant: Report on 738 gastric bypass patients. Obes Surg 14:35–42PubMedCrossRef
10.
go back to reference Novik B, Hagedorn S, Mork UB et al (2006) Fibrin glue for securing the mesh in laparoscopic totally extraperitoneal inguinal hernia repair: a study of a 40-month prospective follow-up. Surg Endosc 20:462–467PubMedCrossRef Novik B, Hagedorn S, Mork UB et al (2006) Fibrin glue for securing the mesh in laparoscopic totally extraperitoneal inguinal hernia repair: a study of a 40-month prospective follow-up. Surg Endosc 20:462–467PubMedCrossRef
11.
go back to reference Olmi S, Scaini A, Erna L et al (2007) Use of fibrin glue (Tissucol®) in laparoscopic repair of abdominal wall defects: preliminary experience. Surg Endosc 21:555–559PubMedCrossRef Olmi S, Scaini A, Erna L et al (2007) Use of fibrin glue (Tissucol®) in laparoscopic repair of abdominal wall defects: preliminary experience. Surg Endosc 21:555–559PubMedCrossRef
12.
go back to reference Lee FY, Leung KL, Lai PB et al (2001) Selection of patients for laparoscopic repair of perforated peptic ulcer. Br J Surg 88:133–136PubMedCrossRef Lee FY, Leung KL, Lai PB et al (2001) Selection of patients for laparoscopic repair of perforated peptic ulcer. Br J Surg 88:133–136PubMedCrossRef
13.
go back to reference Schmal H, Geiger G (2005) Laparoscopic splenic salvage in delayed rupture by application of fibrin glue in a 10-year old boy. J Trauma 58:628–630PubMed Schmal H, Geiger G (2005) Laparoscopic splenic salvage in delayed rupture by application of fibrin glue in a 10-year old boy. J Trauma 58:628–630PubMed
14.
go back to reference Corcione F, Cuccurullo D, Caiazzo P et al (2003) Laparoscopic partial splenectomy for a splenic pseudocyst. Surg Endosc 17:1850PubMed Corcione F, Cuccurullo D, Caiazzo P et al (2003) Laparoscopic partial splenectomy for a splenic pseudocyst. Surg Endosc 17:1850PubMed
15.
go back to reference Chen RJ, Fang JF, Lin BC et al (1998) Selective application of laparoscopy and fibrin glue in the failure of nonoperative management of blunt hepatic trauma. J Trauma 44:691–695PubMedCrossRef Chen RJ, Fang JF, Lin BC et al (1998) Selective application of laparoscopy and fibrin glue in the failure of nonoperative management of blunt hepatic trauma. J Trauma 44:691–695PubMedCrossRef
16.
go back to reference Belli G, Fantini C, D’Agostino A et al (2005) Laparoscopic hepatic resection for completely exophytic hepatocellular carcinoma on cirrhosis. J Hepatobiliary Pancreat Surg 12:488–493PubMedCrossRef Belli G, Fantini C, D’Agostino A et al (2005) Laparoscopic hepatic resection for completely exophytic hepatocellular carcinoma on cirrhosis. J Hepatobiliary Pancreat Surg 12:488–493PubMedCrossRef
17.
go back to reference Takeuchi H, Kitade M, Kikuchi I et al (2005) Adhesion-prevention effects of fibrin sealants after laparoscopy myomectomy determined by second-look laparoscopy: a prospective, randomized, controlled study. J Reprod Med 50:571–577PubMed Takeuchi H, Kitade M, Kikuchi I et al (2005) Adhesion-prevention effects of fibrin sealants after laparoscopy myomectomy determined by second-look laparoscopy: a prospective, randomized, controlled study. J Reprod Med 50:571–577PubMed
18.
go back to reference Nur I, Lyahovetsky Y, Bar L et al (2005) Commercial fibrin sealants are not equivalent in a rabbit liver-resection model which quantitatively evaluates haemostasis and formation of adhesions. Eur Surg Res 37:159–165PubMedCrossRef Nur I, Lyahovetsky Y, Bar L et al (2005) Commercial fibrin sealants are not equivalent in a rabbit liver-resection model which quantitatively evaluates haemostasis and formation of adhesions. Eur Surg Res 37:159–165PubMedCrossRef
19.
go back to reference American Society for Gastrointestinal Endoscopy Technology Assessment Committee (2004) Technology status evaluation report: tissue adhesives and fibrin glues. Gastrointest Endosc 60:327–333CrossRef American Society for Gastrointestinal Endoscopy Technology Assessment Committee (2004) Technology status evaluation report: tissue adhesives and fibrin glues. Gastrointest Endosc 60:327–333CrossRef
20.
go back to reference Liu CD, Glantz GJ, Livingston EH (2003) Fibrin glue as a sealant for high-risk anastomosis in surgery for morbid obesity. Obes Surg 13:45–48PubMedCrossRef Liu CD, Glantz GJ, Livingston EH (2003) Fibrin glue as a sealant for high-risk anastomosis in surgery for morbid obesity. Obes Surg 13:45–48PubMedCrossRef
21.
go back to reference Nguyen NT, Nguyen CT, Stevens CM et al (2004) The efficacy of fibrin sealant in prevention of anastomotic leak after laparoscopic gastric bypass. J Surg Res 122:218–224PubMedCrossRef Nguyen NT, Nguyen CT, Stevens CM et al (2004) The efficacy of fibrin sealant in prevention of anastomotic leak after laparoscopic gastric bypass. J Surg Res 122:218–224PubMedCrossRef
22.
go back to reference Lee MG, Provost DA, Jones DB (2004) Use of fibrin sealant in laparoscopic gastric bypass for morbidly obese. Obes Surg 14:1321–1326PubMedCrossRef Lee MG, Provost DA, Jones DB (2004) Use of fibrin sealant in laparoscopic gastric bypass for morbidly obese. Obes Surg 14:1321–1326PubMedCrossRef
23.
go back to reference Carbajo M, Garcia-Caballero M, Toledano M et al (2005) One anastomosis gastric bypass by laparoscopy: results of the first 209 patients. Obes Surg 15:398–404PubMedCrossRef Carbajo M, Garcia-Caballero M, Toledano M et al (2005) One anastomosis gastric bypass by laparoscopy: results of the first 209 patients. Obes Surg 15:398–404PubMedCrossRef
24.
go back to reference Hutter M, Sheldon R, Khuri S et al (2006) Laparoscopic versus open gastric bypass for morbid obesity: a multicenter, prospective, risk-adjusted analysis from the national surgical quality improvement program. Ann Surg 243:657–666PubMedCrossRef Hutter M, Sheldon R, Khuri S et al (2006) Laparoscopic versus open gastric bypass for morbid obesity: a multicenter, prospective, risk-adjusted analysis from the national surgical quality improvement program. Ann Surg 243:657–666PubMedCrossRef
25.
go back to reference Higa KD, Tienchin Ho, Boone KB (2003) Internal hernias after laparoscopic Roux-en-Y gastric bypass: incidence, treatment and prevention. Obes Surg 13:350–354PubMedCrossRef Higa KD, Tienchin Ho, Boone KB (2003) Internal hernias after laparoscopic Roux-en-Y gastric bypass: incidence, treatment and prevention. Obes Surg 13:350–354PubMedCrossRef
26.
go back to reference Capella RF, Iannace VA (2006) Bowel obstruction after open and laparoscopic gastric bypass surgery for morbid obesity. J Am Coll Surg 203:328–335PubMedCrossRef Capella RF, Iannace VA (2006) Bowel obstruction after open and laparoscopic gastric bypass surgery for morbid obesity. J Am Coll Surg 203:328–335PubMedCrossRef
27.
go back to reference Waage A, Gagner M, Biertho L et al (2005) Comparison between open hand-sewn, laparoscopic stapled and laparoscopic computer-mediated, circular stapled gastro-jejunostomies in Roux-en-Y gastric bypass in the porcine model. Obes Surg 15:782–787PubMedCrossRef Waage A, Gagner M, Biertho L et al (2005) Comparison between open hand-sewn, laparoscopic stapled and laparoscopic computer-mediated, circular stapled gastro-jejunostomies in Roux-en-Y gastric bypass in the porcine model. Obes Surg 15:782–787PubMedCrossRef
28.
go back to reference Silecchia G, Boru CE, Mouiel J et al (2006) Clinical evaluation of fibrin glue in the prevention of anastomotic leak and internal hernia after laparoscopic gastric bypass: preliminary results of a prospective, randomized multicenter trial. Obes Surg 16:125–131PubMedCrossRef Silecchia G, Boru CE, Mouiel J et al (2006) Clinical evaluation of fibrin glue in the prevention of anastomotic leak and internal hernia after laparoscopic gastric bypass: preliminary results of a prospective, randomized multicenter trial. Obes Surg 16:125–131PubMedCrossRef
29.
go back to reference Gastrointestinal surgery for severe obesity (1991) National Institutes of Health Consensus Development Conference Draft Statement. Obes Surg 1:257–266CrossRef Gastrointestinal surgery for severe obesity (1991) National Institutes of Health Consensus Development Conference Draft Statement. Obes Surg 1:257–266CrossRef
30.
go back to reference Gonzalez R, Nelson LG, Scott F et al (2004) Anastomotic leaks after laparoscopic gastric bypass. Obes Surg 14:1299–1337PubMedCrossRef Gonzalez R, Nelson LG, Scott F et al (2004) Anastomotic leaks after laparoscopic gastric bypass. Obes Surg 14:1299–1337PubMedCrossRef
31.
go back to reference Podnos YD, Jiminez JC, Wilson SE et al (2003) Complications after laparoscopic gastric bypass: a review of 3464 cases. Arch Surg 138:957–961PubMedCrossRef Podnos YD, Jiminez JC, Wilson SE et al (2003) Complications after laparoscopic gastric bypass: a review of 3464 cases. Arch Surg 138:957–961PubMedCrossRef
32.
go back to reference Papavramidis ST, Eleftheriadis EE, Papavramidis TS et al (2004) Endoscopic management of gastrocutaneous fistula after bariatric surgery by using a fibrin sealant. Gastrointest Endosc 59:296–300PubMedCrossRef Papavramidis ST, Eleftheriadis EE, Papavramidis TS et al (2004) Endoscopic management of gastrocutaneous fistula after bariatric surgery by using a fibrin sealant. Gastrointest Endosc 59:296–300PubMedCrossRef
33.
go back to reference Eleftheriadis E, Tzartinoglou E, Kotzampassi K et al (1990) Early endoscopic fibrin sealing of high-output postoperative enterocutaneous fistulas. Acta Chir Scand 156:625–628PubMed Eleftheriadis E, Tzartinoglou E, Kotzampassi K et al (1990) Early endoscopic fibrin sealing of high-output postoperative enterocutaneous fistulas. Acta Chir Scand 156:625–628PubMed
34.
go back to reference Truong S, Bohm G, Klinge U et al (2004) Results after endoscopic treatment of postoperative gastrointestinal fistulas and leaks using combined Vycril plug and fibrin sealant. Surg Endosc 18:1105–1108PubMedCrossRef Truong S, Bohm G, Klinge U et al (2004) Results after endoscopic treatment of postoperative gastrointestinal fistulas and leaks using combined Vycril plug and fibrin sealant. Surg Endosc 18:1105–1108PubMedCrossRef
Metadata
Title
The use of fibrin sealant to prevent major complications following laparoscopic gastric bypass: results of a multicenter, randomized trial
Authors
Gianfranco Silecchia
Cristian Eugeniu Boru
Jean Mouiel
Marco Rossi
Marco Anselmino
Mario Morino
Mario Toppino
Achille Gaspari
Paolo Gentileschi
Roberto Tacchino
Nicola Basso
Publication date
01-11-2008
Publisher
Springer-Verlag
Published in
Surgical Endoscopy / Issue 11/2008
Print ISSN: 0930-2794
Electronic ISSN: 1432-2218
DOI
https://doi.org/10.1007/s00464-008-9885-0

Other articles of this Issue 11/2008

Surgical Endoscopy 11/2008 Go to the issue