Bovine Reinforcement in Stomach, Colorectal and Lung Operation (123)

  • STATUS
    Recruiting
  • End date
    Oct 31, 2026
  • participants needed
    172
  • sponsor
    Shanghai Cingularbio Co. Ltd
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Updated on 14 May 2025
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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.

Description

This is a randomized prospective trial that compares the use of Cingular Bioabsorbable Staple Line Reinforcement to standard stapling techniques in tissue resections. The potential exists to utilize staple line reinforcement as a means of lowering the rate of post-operative hemorrage rate, anastomotic leakage.

Details
Condition Rectal Cancer, Lung Cancer
Age 18years - 75years
Clinical Study IdentifierNCT06968221
SponsorShanghai Cingularbio Co. Ltd
Last Modified on14 May 2025

Eligibility

 Yes No Not Sure

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
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