Bovine Reinforcement in Stomach, Colorectal and Lung Operation

Phase 3RecruitingNCT06968221

Shanghai Cingularbio Co. Ltd172 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

172

Conditions

Rectal Cancer Stage III Lung Cancer Stage III

Interventions

Bioabsorbable Staple Line ReinforcemenDEVICE

cingular Bioabsorbable Staple Line Reinforcement

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Renji hospital affiliated to Shanghai jiaotong Uni school of medicine

Shanghai, China

RECRUITING

Outcomes

Primary Outcomes

Proportion of Subjects Who Experience a hemorrage

The primary endpoint for the study is the proportion of subjects who experience a hemorrage through 10 min post procedure.

Time frame: 10 min

Secondary Outcomes

Proportion of Subjects Who Experience a Clinical and/or Radiologic Anastomotic Leak

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.

Time frame: 1-3 months

Central Contacts

study director

CONTACT

02138016387 july_s@126.com

Data from ClinicalTrials.gov

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