Fibrin-based Biological Adhesives Prevent Anastomotic Leakage in Rectal Anastomoses: Prospective Multicentre Randomised Clinical Trial

Jesús Lago Oliver; Salvador Argudo Garijo; Mauricio Burneo Esteves; Irene Arjona Medina; Mercedes Sanz Sánchez; Jorge Martín Gil; Fernando Turégano Fuentes; Antonio Torres García

doi:doi:10.11648/j.js.20150303.13

Fibrin-based Biological Adhesives Prevent Anastomotic Leakage in Rectal Anastomoses: Prospective Multicentre Randomised Clinical Trial

Jesús Lago Oliver, Salvador Argudo Garijo, Mauricio Burneo Esteves, Irene Arjona Medina, Mercedes Sanz Sánchez, Jorge Martín Gil, Fernando Turégano Fuentes, Antonio Torres García

Published in Journal of Surgery (Volume 3, Issue 3)

Received: 30 April 2015 Accepted: 9 May 2015 Published: 21 May 2015

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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.

Published in	Journal of Surgery (Volume 3, Issue 3)
DOI	10.11648/j.js.20150303.13
Page(s)	26-31
Creative Commons	This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.
Copyright	Copyright © The Author(s), 2015. Published by Science Publishing Group

Keywords

Fibrin Tissue Adhesive, Anastomotic Leak, Digestive System Surgical Procedures, Randomized Controlled Trial, Spain

References

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APA Style

Jesús Lago Oliver, Salvador Argudo Garijo, Mauricio Burneo Esteves, Irene Arjona Medina, Mercedes Sanz Sánchez, et al. (2015). Fibrin-based Biological Adhesives Prevent Anastomotic Leakage in Rectal Anastomoses: Prospective Multicentre Randomised Clinical Trial. Journal of Surgery, 3(3), 26-31. https://doi.org/10.11648/j.js.20150303.13

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ACS Style

Jesús Lago Oliver; Salvador Argudo Garijo; Mauricio Burneo Esteves; Irene Arjona Medina; Mercedes Sanz Sánchez, et al. Fibrin-based Biological Adhesives Prevent Anastomotic Leakage in Rectal Anastomoses: Prospective Multicentre Randomised Clinical Trial. J. Surg. 2015, 3(3), 26-31. doi: 10.11648/j.js.20150303.13

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AMA Style

Jesús Lago Oliver, Salvador Argudo Garijo, Mauricio Burneo Esteves, Irene Arjona Medina, Mercedes Sanz Sánchez, et al. Fibrin-based Biological Adhesives Prevent Anastomotic Leakage in Rectal Anastomoses: Prospective Multicentre Randomised Clinical Trial. J Surg. 2015;3(3):26-31. doi: 10.11648/j.js.20150303.13

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@article{10.11648/j.js.20150303.13,
  author = {Jesús Lago Oliver and Salvador Argudo Garijo and Mauricio Burneo Esteves and Irene Arjona Medina and Mercedes Sanz Sánchez and Jorge Martín Gil and Fernando Turégano Fuentes and Antonio Torres García},
  title = {Fibrin-based Biological Adhesives Prevent Anastomotic Leakage in Rectal Anastomoses: Prospective Multicentre Randomised Clinical Trial},
  journal = {Journal of Surgery},
  volume = {3},
  number = {3},
  pages = {26-31},
  doi = {10.11648/j.js.20150303.13},
  url = {https://doi.org/10.11648/j.js.20150303.13},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.js.20150303.13},
  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.},
 year = {2015}
}

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TY - JOUR
T1 - Fibrin-based Biological Adhesives Prevent Anastomotic Leakage in Rectal Anastomoses: Prospective Multicentre Randomised Clinical Trial
AU - Jesús Lago Oliver
AU - Salvador Argudo Garijo
AU - Mauricio Burneo Esteves
AU - Irene Arjona Medina
AU - Mercedes Sanz Sánchez
AU - Jorge Martín Gil
AU - Fernando Turégano Fuentes
AU - Antonio Torres García
Y1 - 2015/05/21
PY - 2015
N1 - https://doi.org/10.11648/j.js.20150303.13
DO - 10.11648/j.js.20150303.13
T2 - Journal of Surgery
JF - Journal of Surgery
JO - Journal of Surgery
SP - 26
EP - 31
PB - Science Publishing Group
SN - 2330-0930
UR - https://doi.org/10.11648/j.js.20150303.13
AB - 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.
VL - 3
IS - 3
ER -

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Author Information

Jesús Lago Oliver

Department of Surgery, University General Hospital Gregorio Mara?ón, Madrid, Spain
Salvador Argudo Garijo

Department of Surgery, Southeast Hospital, Madrid, Spain
Mauricio Burneo Esteves

Department of Surgery, University General Hospital Gregorio Mara?ón, 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 Mara?ón, Madrid, Spain
Jorge Martín Gil

Department of Surgery, University General Hospital Gregorio Mara?ón, Madrid, Spain
Fernando Turégano Fuentes

Department of General Surgery II, University General Hospital Gregorio Mara?ón, Madrid, Spain
Antonio Torres García

Department of Surgery, San Carlos University Hospital, Madrid, Spain

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APA Style

Jesús Lago Oliver, Salvador Argudo Garijo, Mauricio Burneo Esteves, Irene Arjona Medina, Mercedes Sanz Sánchez, et al. (2015). Fibrin-based Biological Adhesives Prevent Anastomotic Leakage in Rectal Anastomoses: Prospective Multicentre Randomised Clinical Trial. Journal of Surgery, 3(3), 26-31. https://doi.org/10.11648/j.js.20150303.13

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ACS Style

Jesús Lago Oliver; Salvador Argudo Garijo; Mauricio Burneo Esteves; Irene Arjona Medina; Mercedes Sanz Sánchez, et al. Fibrin-based Biological Adhesives Prevent Anastomotic Leakage in Rectal Anastomoses: Prospective Multicentre Randomised Clinical Trial. J. Surg. 2015, 3(3), 26-31. doi: 10.11648/j.js.20150303.13

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AMA Style

Jesús Lago Oliver, Salvador Argudo Garijo, Mauricio Burneo Esteves, Irene Arjona Medina, Mercedes Sanz Sánchez, et al. Fibrin-based Biological Adhesives Prevent Anastomotic Leakage in Rectal Anastomoses: Prospective Multicentre Randomised Clinical Trial. J Surg. 2015;3(3):26-31. doi: 10.11648/j.js.20150303.13

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@article{10.11648/j.js.20150303.13,
  author = {Jesús Lago Oliver and Salvador Argudo Garijo and Mauricio Burneo Esteves and Irene Arjona Medina and Mercedes Sanz Sánchez and Jorge Martín Gil and Fernando Turégano Fuentes and Antonio Torres García},
  title = {Fibrin-based Biological Adhesives Prevent Anastomotic Leakage in Rectal Anastomoses: Prospective Multicentre Randomised Clinical Trial},
  journal = {Journal of Surgery},
  volume = {3},
  number = {3},
  pages = {26-31},
  doi = {10.11648/j.js.20150303.13},
  url = {https://doi.org/10.11648/j.js.20150303.13},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.js.20150303.13},
  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.},
 year = {2015}
}

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