Safety and Effectiveness of Using Cingular Bovine Pericardium Membrane to Reinforce and Control Bleeding in Stomach, Colorectal, and Lung Surgery Anastomoses

What this Trial Is About

Researchers are evaluating the safety and outcomes of using a bioabsorbable staple line reinforcement material during surgeries involving stomach, colorectal, and lung anastomoses. This randomized, prospective, multicenter study compares this reinforcement technique to standard stapling methods to see if it reduces the rate of postoperative bleeding and anastomotic leakage. The study is sponsored by Shanghai Cingularbio Co. Ltd and is conducted in a Phase 3 setting. Participants will receive one of two surgical approaches either the anastomotic staple line is reinforced with the Cingular Bioabsorbable Staple Line Reinforcement configured for circular staplers, or the staple line is created without reinforcement using standard techniques. The trial focuses on tissue resections performed with these methods to evaluate their impact on surgical outcomes. During the study, participants will be monitored for the occurrence of hemorrhage within 10 minutes after surgery and for clinical or radiologic signs of anastomotic leaks within 1 to 3 months following the procedure. Follow-up visits will assess these outcomes as well as overall safety. The total participation period spans from surgery through the follow-up timeline. Researchers will collect data on postoperative bleeding, leaks, and adverse events to determine the comparative safety and efficacy of the reinforcement device.

Bovine Reinforcement in Stomach, Colorectal and Lung Operation