Bovine Reinforcement in Stomach, Colorectal and Lung Operation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bioabsorbable Staple Line Reinforcemen.
- Who it may be relevant to
- Registry conditions: Rectal Cancer Stage III, Lung Cancer Stage III. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Study on the Safety and Efficacy of Using Cingular Bovine Pericardium Anastomosis Reinforcement Membrane for Tissue Reinforcement and Hemostasis at Anastomotic Sites
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.
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.
Interventions
- Device Bioabsorbable Staple Line Reinforcemen
cingular Bioabsorbable Staple Line Reinforcement
Primary outcome measures
- Proportion of Subjects Who Experience a hemorrage [Time frame: 10 min]
Secondary outcome measures (1)
- Proportion of Subjects Who Experience a Clinical and/or Radiologic Anastomotic Leak [Time frame: 1-3 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Renji hospital affiliated to Shanghai jiaotong Uni school of medicine — Shanghai
Identifiers
NCT: NCT06968221 · BSLR-2024-01