Fibrin-based Biological Adhesives Prevent Anastomotic Leakage in Rectal Anastomoses: Prospective Multicentre Randomised Clinical Trial
Journal of Surgery
Volume 3, Issue 3, June 2015, Pages: 26-31
Received: Apr. 30, 2015;
Accepted: May 9, 2015;
Published: May 21, 2015
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Jesús Lago Oliver, Department of Surgery, University General Hospital Gregorio Marañón, Madrid, Spain
Salvador Argudo Garijo, Department of Surgery, Southeast Hospital, Madrid, Spain
Mauricio Burneo Esteves, Department of Surgery, University General Hospital Gregorio Marañón, Madrid, Spain
Irene Arjona Medina, Department of Surgery, General Hospital of Ciudad Real, Ciudad Real, Spain
Mercedes Sanz Sánchez, Department of Surgery, University General Hospital Gregorio Marañón, Madrid, Spain
Jorge Martín Gil, Department of Surgery, University General Hospital Gregorio Marañón, Madrid, Spain
Fernando Turégano Fuentes, Department of General Surgery II, University General Hospital Gregorio Marañón, Madrid, Spain
Antonio Torres García, Department of Surgery, San Carlos University Hospital, Madrid, Spain
Background: Fibrin-based biological adhesives are used for tissue adhesion improving the outcome of gastrointestinal sutures. The objective was to assess the effectiveness of fibrin-based biological adhesives for prevention of anastomotic leakage in high-risk gastrointestinal anastomoses. Methods: A randomized clinical trial was designed to recruit patients underwent a rectal resection surgery. A subgroup of patients with rectal anastomosis were recruited from 2 different hospital centres. Patients in which a biological fibrin-based biological adhesive was applied to the suture line (study group) were compared versus a control group under standard practice. The main outcome measures was presence or absence of leakage and need for reoperation. Results: Thirty seven patients underwent a rectal resection and anastomosis. In 21 standard practice was applied and a fibrin-based adhesive was used in 16. Fourteen patients (37.8%) had a clinical or subclinical anastomotic leak, 11 belonging to control group versus 3 patients in the study group (p-value of 0.04). Statistically significant difference (p-value of 0.048) in the need for reoperation. We found no association between the use of drains and anastomotic leakage. There were only 3 leaks in the group in which a drain was placed, as compared to 11 leaks in the group in which no drain was placed, but these findings were probably due to chance (p = 0.54). Conclusions: The use of these adhesives could not only reduce serious postoperative complications related to dehiscence but also improve the prognosis and oncological outcome of rectal and sigmoid cancer treatment.
Jesús Lago Oliver,
Salvador Argudo Garijo,
Mauricio Burneo Esteves,
Irene Arjona Medina,
Mercedes Sanz Sánchez,
Jorge Martín Gil,
Fernando Turégano Fuentes,
Antonio Torres García,
Fibrin-based Biological Adhesives Prevent Anastomotic Leakage in Rectal Anastomoses: Prospective Multicentre Randomised Clinical Trial, Journal of Surgery.
Vol. 3, No. 3,
2015, pp. 26-31.
Schnüriger B, Inaba K, Wu T, Eberle BM, Belzberg H, Demetriades D. Crystalloids after primary colon resection and anastomosis at initial trauma laparotomy: excessive volumes are associated with anastomotic leakage. J Trauma. 2011;70:603-10.
Poon RT, Fan ST. Decreasing the pancreatic leak rate after pancreaticoduodenectomy. Adv Surg. 2008;42:33-48.
Ben-David K, Sarosi GA, Cendan JC, Howard D, Rossidis G, Hochwald SN. Decreasing morbidity and mortality in 100 consecutive minimally invasive esophagectomies. Surg Endosc. 2011;26:162-7.
Ivanov D, Cvijanović R, Gvozdenović L. Intraoperative air testing of colorectal anastomoses. Srp Arh Celok Lek. 2011;139:333-8.
Lin SC, Chen PC, Lee CT, et al. Routine defunctioning stoma after chemoradiation and total mesorectal excision: a single-surgeon experience. World J Gastroenterol. 2013;19:1797-1804.
Seo SI, Yu CS, Kim GS, et al. The role of diverting stoma after an ultra-low anterior resection for rectal cancer. Ann Coloproctol. 2013;29:66-71.
Park JS, Choi GS, Kim SH, et al. Multicenter analysis of risk factors for anastomotic leakage after laparoscopic rectal cancer excision: the Korean laparoscopic colorectal surgery study group. Ann Surg. 2013;257:665-71.
Smith JD, Butte JM, Weiser MR, et al. Anastomotic leak following low anterior resection in stage IV rectal cancer is associated with poor survival. Ann Surg Oncol. 2013;20:2641-6.
Law WL, Choi HK, Lee YM, Ho JW, Seto CL. Anastomotic leakage is associated with poor long-term outcome in patients after curative colorectal resection for malignancy. J Gastrointest Surg. 2007;11:8-15.
Arteaga-González IJ. A revolutionary design change to improve stapler safety. Obes Surg. 2013;23:112-4.
Honda M, Kuriyama A, Noma H, Nunobe S, Furukawa TA. Hand-sewn versus mechanical esophagogastric anastomosis after esophagectomy: a systematic review and meta-analysis. Ann Surg. 2013;257:238-248.
Sajid MS, Hutson KH, Rapisarda IF, Bonomi R. Fibrin glue instillation under skin flaps to prevent seroma-related morbidity following breast and axillary surgery. Cochrane Database Syst Rev. 2013;5:CD009557.
Kobayashi S, Nagano H, Marubashi S, et al. Fibrin sealant with PGA felt for prevention of bile leakage after liver resection. Hepatogastroenterology. 2012;59:2564-8.
Sanders DL, Waydia S. A systematic review of randomised control trials assessing mesh fixation in open inguinal hernia repair. Hernia. 2013 May 7. [Epub ahead of print].
Tolver MA, Rosenberg J, Juul P, Bisgaard T. Randomised clinical trial of fibrin glue versus tacked fixation in laparoscopic groin hernia repair. Surg Endosc. 2013;27:2727-33.
Prieto-Díaz-Chávez E, Medina-Chávez JL, Ramírez-Barba EJ, Trujillo-Hernández B, Millán-Guerrero RO, Vásquez C. Reduction of peritoneal adhesion to polypropylene mesh with the application of fibrin glue. Acta Chir Belg. 2008;108:433-7.
Giuratrabocchetta S, Rinaldi M, Cuccia F, et al. Protection of intestinal anastomosis with biological glues: an experimental randomised controlled trial. Tech Coloproctol. 2011;15:153-8.
Herreros MD, Garcia-Arranz M, Guadalajara H, De-La-Quintana P, Garcia-Olmo D. FATT Collaborative Group: Autologous expanded adipose-derived stem cells for the treatment of complex cryptoglandular perianal fistulas: a phase III randomised clinical trial (FATT 1: fistula Advanced Therapy Trial 1) and long-term evaluation. Dis Colon Rectum. 2012;55:762-72.
Silecchia G, Boru CE, Mouiel J, et al. Clinical evaluation of fibrin glue in the prevention of anastomotic leak and internal hernia after laparoscopic gastric bypass: preliminary results of a prospective, randomised multicenter trial. Obes Surg. 2006;16:125-131.
Silecchia G, Boru CE, Mouiel J, et al. The use of fibrin sealant to prevent major complications following laparoscopic gastric bypass: results of a multicenter, randomised trial. Surg Endosc. 2008;22:2492-7.
Fernandez Fernandez L, Tejero E, Tieso A. Randomised trial of fibrin glue to seal mechanical oesophagojejunal anastomosis. Br J Surg. 1996;83:40-1.
De Almeida JR, Ghotme K, Leong I, Drake J, James AL, Witterick IJ. A new porcine skull base model: fibrin glue improves strength of cerebrospinal fluid leak repairs. Otolaryngol Head Neck Surg. 2009;141:184-9.
Bonanomi G, Prince JM, McSteen F, Schauer PR, Hamad GG. Sealing effect of fibrin glue on the healing of gastrointestinal anastomoses: implications for the endoscopic treatment of leaks. Surg Endosc. 2004;18:1620-4.
Suc B, Msika S, Fingerhut A, et al. Temporary fibrin glue occlusion of the main pancreatic duct in the prevention of intra-abdominal complications after pancreatic resection: prospective randomised trial. Ann Surg. 2003;237:57-65.
Lillemoe KD, Cameron JL, Kim MP, et al. Does fibrin glue sealant decrease the rate of pancreatic fistula after pancreaticoduodenectomy? Results of a prospective randomised trial. J Gastrointest Surg. 2004;8:766-74.
Morikawa T. Tissue sealing. Am J Surg. 2001;182:29S-35S.
Baker RS, Foote J, Kemmeter P, Brady R, Vroegop T, Serveld M. The science of stapling and leaks. Obes Surg. 2004;14:1290-8.
Herreros MD, Garcia-Arranz M, Guadalajara H, De-La-Quintana P, Garcia-Olmo D; FATT Collaborative Group. Autologous expanded adipose-derived stem cells for the treatment of complex cryptoglandular perianal fistulas: a phase III randomised clinical trial (FATT 1: fistula Advanced Therapy Trial 1) and long-term evaluation. Dis Colon Rectum. 2012;55:762-72.
Salgado W Jr, Cunha Fde Q, dos Santos JS, et al. Routine abdominal drains after Roux-en-Y gastric bypass: a prospective evaluation of the inflammatory response. Surg Obes Relat Dis. 2010;6:648-52.
Akiyoshi T, Ueno M, Fukunaga Y, et al. Incidence of and risk factors for anastomotic leakage after laparoscopic anterior resection with intracorporeal rectal transection and double-stapling technique anastomosis for rectal cancer. Am J Surg. 2011;202:259-64.