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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Authors
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
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Abstract
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.
Keywords
Fibrin Tissue Adhesive, Anastomotic Leak, Digestive System Surgical Procedures, Randomized Controlled Trial, Spain
To cite this article
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. doi: 10.11648/j.js.20150303.13
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