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
Shanghai Cingularbio Co. Ltd
172 participants
May 1, 2025
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
Inclusion Criteria2
- Subjects who will undergo operation with stapled stomach, colorectal anastomosis with or without reinforcement
- Subjects willing to accept informed consent and willing to attend the follow up
Exclusion Criteria3
- Subjects who have significant intraoperative hypotension or cardiac events.
- Subjects with collagen vascular disease, coagulopathy, significant renal or hepatic dysfunction (creatinine \>1.6 or liver enzymes \> 50% upper limit of normal values).
- Subjects have uncontrolled intra-abdominal infection
Interventions
cingular Bioabsorbable Staple Line Reinforcement
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06968221