Clinical Research Studies

This study is designed as a prospective, multi-center, multinational randomized, single-blind, double armed study with either open, laparoscopic or robot assisted procedure. The study is classified as a post marketing interventional study in Europe, and as a pre-market approval study in the USA. Postoperative anastomotic leakage is one of the most devastating and feared complications in colorectal surgery. The risk of postoperative anastomotic leakage varies widely depending on the level of anastomosis while the risk is higher in low anastomosis. LifeSeal™ Kit, surgical sealant designed for staple-line reinforcement that is applied over the anastomotic line to prevent bowel content leakage until full physiological function is restored. The sealant is composed of gelatin. The sealant is applied over the intestine connection and has the potential to physically block the intestinal content from leaking through the created connection. The gelatin layer is biodegradable and almost no sealant is left approximately 1 year after surgery. Subjects who are not treated with LifeSeal™ Kit will have the surgical procedure per the routine clinical practice. Anastomosis will be performed without any reinforcement. In order to best demonstrate the benefits of LifeSeal™ in providing staple line reinforcement and helping to reduce leaks, the study includes high risk anastomoses, defined as colorectal and coloanal anastomoses performed within 10 cm from the anal verge. Subjects will be on study for up to 2 years after surgery. Up to 736 subjects will be randomized on a 1:1 basis.