Bovine Reinforcement in Stomach, Colorectal and Lung Operation

Phase 3

Recruiting

• Conditions: Rectal Cancer Stage III; Lung Cancer Stage III

• Registration Number: NCT06968221
• Lead Sponsor: Shanghai Cingularbio Co. Ltd

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2025-05
• Study Start: 2025-05-01
• Study First Submitted: 2025-05-05
• Study First Submitted QC: 2025-05-05
• Last Update Submitted: 2025-05-12
• Study First Posted: 2025-05-13
• Last Update Posted: 2025-05-15
• Primary Completion: 2025-09-01
• Study Completion: 2026-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 172

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of Subjects Who Experience a hemorrage	10 min	The primary endpoint for the study is the proportion of subjects who experience a hemorrage through 10 min post procedure.

Secondary Outcome Measures

Name	Time	Method
Proportion of Subjects Who Experience a Clinical and/or Radiologic Anastomotic Leak	1-3 months	The primary endpoint for the study is the proportion of subjects who experience a clinical and/or radiologic anastomotic leak through 1-3 months post procedure.

Trial Locations

Locations (1)

Renji hospital affiliated to Shanghai jiaotong Uni school of medicine; 🇨🇳 Shanghai, China