Magen-Darm- und Verdauungssystem

Abstrakt

A Gelatin-Based Prophylactic Sealant for Bowel Wall Closure, Initial Evaluation in Mid-rectal Anastomosis in a Large Animal Model

Yael Kopelman, Yael Nir, Yariv Siman-Tov, Benjamin Person, Oded Zmora, Hagit Tolchinski, Amir Szold, Doron Kopelman

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.