Using bioabsorbable staples to improve surgery outcomes for rectal and lung cancer
A Study on the Safety and Efficacy of Using Cingular Bovine Pericardium Anastomosis Reinforcement Membrane for Tissue Reinforcement and Hemostasis at Anastomotic Sites
This study is testing if using special dissolvable staples during stomach, colorectal, and lung surgeries can help patients have fewer complications after their operations compared to regular staples.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 172 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shanghai Cingularbio Co. Ltd Industry-sponsored |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06968221 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a bioabsorbable staple line reinforcement material in comparison to standard stapling techniques during stomach, colorectal, and lung surgeries. It is a randomized, prospective multicenter study aimed at reducing postoperative complications such as hemorrhage and anastomotic leakage. Participants will be monitored for outcomes related to these complications following their surgeries. The study seeks to determine if the new reinforcement material can provide better surgical results.
Who should consider this trial
Good fit: Ideal candidates include patients scheduled for stapled stomach or colorectal surgeries who can provide informed consent.
Not a fit: Patients with significant intraoperative complications, collagen vascular diseases, or uncontrolled infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative complications for patients undergoing surgery for rectal and lung cancer.
How similar studies have performed: While the use of bioabsorbable materials in surgical procedures is gaining interest, this specific application in colorectal and lung surgeries is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai
- Renji hospital affiliated to Shanghai jiaotong Uni school of medicine — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: study director
- Email: july_s@126.com
- Phone: 02138016387
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.