Bovine Reinforcement in Stomach, Colorectal and Lung Operation

Shanghai Cingularbio

Status and phase: Enrolling; Phase 3

Conditions: Rectal Cancer Stage III; Lung Cancer Stage III

Treatments: Device: Bioabsorbable Staple Line Reinforcemen

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06968221

BSLR-2024-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 172 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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172 participants in 2 patient groups

Bioabsorbable Staple Line Reinforcement configured for circular staplers

Experimental group

Description:

stomach, Colorectal and lung anastomotic staple line reinforcement with Bioabsorbable Staple Line Reinforcement configured for circular staple

Treatment:

Device: Bioabsorbable Staple Line Reinforcemen

anastomotic staple line without reinforcement

Active Comparator group

Description:

stomach, colorectal and lung anastomotic staple line without reinforcement

Treatment:

Device: Bioabsorbable Staple Line Reinforcemen