Predicting delayed bleeding after polyp removal in the colon
FIT for Post poLypectomy bLeeding Prediction
Carol Davila University of Medicine and Pharmacy · NCT06220149
This study is testing whether a daily stool test can help doctors predict which patients might have delayed bleeding after having polyps removed from their colon.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Carol Davila University of Medicine and Pharmacy (other) |
| Locations | 1 site (Bucharest) |
| Trial ID | NCT06220149 on ClinicalTrials.gov |
What this trial studies
This observational study aims to predict the occurrence of delayed post polypectomy bleeding (DPPB) in patients who have undergone endoscopic removal of colorectal polyps. It will utilize a fecal immunochemical test (FIT) administered daily for two weeks following the polypectomy to identify patients at risk for DPPB. The study will analyze various risk factors, including polyp size and patient demographics, to enhance prediction accuracy. By understanding these risks, the study seeks to improve patient management and outcomes post-procedure.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who have had at least one advanced adenoma larger than 10mm removed during colonoscopy.
Not a fit: Patients with synchronous advanced colorectal cancer, unresected advanced adenomas, or active inflammatory bowel disease will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better risk assessment and management strategies for patients undergoing polypectomy, potentially reducing the incidence of delayed bleeding.
How similar studies have performed: Previous studies have shown varying success in predicting DPPB using different risk factors, but this specific approach using FIT is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient with at least one advanced adenoma \> 10mm diameter resected at colonoscopy by polypectomy, EMR, underwater EMR or ESD * Age \> 18 years old * Written informed consent. Exclusion Criteria: * Synchronous advanced colorectal cancer * Synchronous unresected advanced adenomas * Concomitant inflammatory bowel disease or any active colitis * Absence of written informed consent
Where this trial is running
Bucharest
- "Agrippa Ionescu" Hospital — Bucharest, Romania (RECRUITING)
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.
Conditions: Polyp Colorectal, Bleeding