Post Polypectomy Bleeding. Que Sera, Sera? Whatever Will be, Will be? (NCT06220149) | Clinical Trial Compass
UnknownNot Applicable
Post Polypectomy Bleeding. Que Sera, Sera? Whatever Will be, Will be?
Romania200 participantsStarted 2024-05-06
Plain-language summary
Patients with colorectal polyps removed endoscopically (polypectomy, endoscopic mucosal resection, underwater endoscopic mucosal resection, endoscopic submucosal dissection) may experience delayed post polypectomy bleeding. The incidence is about one in 40 cases.
There are risks factors for this complication, depending on the polyp type, patient demographics and co-morbidities and polypectomy technique. There are meta-analysis and nomograms for risk prediction available.
We will try to predict delayed post polypectomy bleeding by using FIT (fecal immunochemical test), with a cut-off adapted to detect post polypectomy bleeding, administered daily for 2 weeks after polypectomy.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Day of maximum probability of positive FIT to detect delayed post polypectomy bleeding
Timeframe: 14 days
Trial details
NCT IDNCT06220149
SponsorCarol Davila University of Medicine and Pharmacy