RecruitingPhase 3NCT06968221

Bovine Reinforcement in Stomach, Colorectal and Lung Operation

A Study on the Safety and Efficacy of Using Cingular Bovine Pericardium Anastomosis Reinforcement Membrane for Tissue Reinforcement and Hemostasis at Anastomotic Sites


Sponsor

Shanghai Cingularbio Co. Ltd

Enrollment

172 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The primary purpose of this prospective, randomized multicenter center study is to evaluate and compare the outcomes of stomach,colorectal and lung anastomoses reinforced with a bioabsorbable staple line reinforcement material compared with standard non-reinforced techniques with respect to the incidence of postoperative hemorrage rate, anastomotic leakage, if applicable.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing surgical outcomes in patients who have stomach or colorectal surgery that uses staples to join tissue together — with or without an additional reinforcing material made from bovine (cow-derived) tissue — to see which approach leads to fewer complications. **You may be eligible if...** - You are scheduled for stomach surgery or a bowel (colorectal) operation that involves stapling tissue together - You are willing to provide consent and attend follow-up appointments **You may NOT be eligible if...** - You experienced major drops in blood pressure or heart problems during your operation - You have a connective tissue disease, a bleeding disorder, or significant kidney or liver problems - You have an uncontrolled infection inside your abdomen Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEBioabsorbable Staple Line Reinforcemen

cingular Bioabsorbable Staple Line Reinforcement


Locations(1)

Renji hospital affiliated to Shanghai jiaotong Uni school of medicine

Shanghai, China

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NCT06968221


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