Research Article
A Gelatin-Based Prophylactic Sealant for Bowel Wall Closure, Initial Evaluation in Mid-rectal Anastomosis in a Large Animal Model
Yael Kopelman1,2, Yael Nir3, Yariv Siman-Tov4, Benjamin Person2,5, Oded Zmora6,7, Hagit Tolchinski7,8, Amir Szold9 and Doron Kopelman2,10*1Gastroenterology Institute, Hillel-Yaffe Medical Center, Hadera, Israel
2Rappaport Faculty of Medicine of the Technion – Israel institute of technology, Haifa, Israel
3LifeBond Medical Technologies Ltd., Caesarea, Israel
4Pre-clinical Research Unit at Assaf Harofe Medical Center, Zrifin, Israel
5Department of Surgery, Carmel medical center, Haifa, Israel
6Department of Surgery, Sheba Medical Center, Tel Hashomer, Israel
7Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
8Department of Surgery, Tel Aviv Medical Center, Tel Aviv, Israel
9Assia Medical Group, Tel Aviv, Israel
10Deaprtment of Surgery, HaEmek Medical Center, Afula, Israel
- *Corresponding Author:
- Prof. Doron Kopelman
Head Dept. of surgery, "HaEmek" Medical Center
Yitzhak Rabin Av. Afula, Israel
Tel : 972-547-390939
E-mail: kopelmand@bezeqint.net
Received date: November 17, 2014; Accepted date: February 27, 2015; Published date: March 10, 2015
Citation: Kopelman Y, Nir Y, Siman-Tov Y, Person B, Zmora O, et al. (2015) A Gelatin-Based Prophylactic Sealant for Bowel Wall Closure, Initial Evaluation in Mid-rectal Anastomosis in a Large Animal Model . J Gastrointest Dig Syst 5:258. doi:10.4172/2161-069X.1000258
Copyright: © 2015 Kopelman Y, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Abstract
Background: Leakage is the most significant complication of gastrointestinal surgery and advanced endoscopic procedures. Sealants applied over the closure lines may help in the prevention of leakage by reinforcing the anastomosis during the initial susceptible healing period, allowing the natural healing process additional time by mechanically supporting the bowel edges.
Objective: To evaluate the safety and performance of a gelatin-based sealant in a porcine model.
Design: A prospective double arm, randomized study of 21 pigs, 12 in the sealant study group and 9 controls.
Setting: Animal laboratory
Main Outcome Measurements: Animal wellbeing, radiological contrast studies, gross intra-abdominal pathology and histological evaluation at post-operative days 5, 7, and 10.
Intervention: Transection and re-anastomosing of the mid-rectum
Results: In all 12 sealant arm animals, bowel motility was restored within 24 hours. No adverse effects were detected. No significant difference was noted in type or severity of adhesions. All but one demonstrated a full staple line coverage, transparency, flexibility and perfect adherence of the sealant. Contrast studies did not show leakage. The local wound healing process in both groups was identical, as assessed by histology. The tissue reaction to the sealant was characterized by a capsular formation on the outer surface, mimicking a serosal layer.
Limitation: Differences between porcine and human colorectal anatomy
Conclusions: A gelatin-based liquid sealant is safe to use on colorectal closure in a swine model and shows a favorable performance profile. Clinical studies are required in order to evaluate its efficacy in reducing the rate of gastrointestinal anastomotic leakage.
