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Bovine Reinforcement in Stomach, Colorectal and Lung Operation

RECRUITINGPhase 3Sponsored by Shanghai Cingularbio Co. Ltd
Actively Recruiting
PhasePhase 3
SponsorShanghai Cingularbio Co. Ltd
Started2025-05-01
Est. completion2025-09-01
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted

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

Age: 18 Years – 75 YearsHealthy volunteers accepted
Inclusion Criteria:

* 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 Criteria:

* 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

Conditions4

CancerLung CancerLung Cancer Stage IIIRectal Cancer Stage III

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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