Clip, Endoscopic Resection, Haemorrhage, Non-pedunculated Lesions
Conditions
Brief summary
An simple-blind, randomized study, to evaluate the efficacy and safety of complete closure with clips of mucosal defects after endoscopic mucosal resection (EMR) of large non-pedunculated colorectal lesions (≥ 2 cm) as prophylaxis of delayed bleeding.
Interventions
DEVICEClip closure
Complete clip closure of secondary lesions after the endoscopic mucosal resection
PROCEDURENo clip closure
Observation: no clip closure of secondary lesions after the endoscopic mucosal resection
Sponsors
Fundacion Miguel Servet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years and older * Clinical indication of endoscopic mucosal resection for large-sized (≥ 2cm) non-pedunculated colorectal lesions. * Medium-high risk of delayed bleeding (DB risk score ≥ 4) * Informed consent.
Exclusion criteria
* Patients with colorectal non-pedunculated lesions without endoscopic mucosal resection indication. * Lesions resected by endoscopic submucosal resection. * Incomplete resections. * Resections with suspected deep submucosal invasion. * Mucosal defects treated with clips for known or suspected damage to the muscle layer. * Lesions with low risk of delayed bleeding (DB risk score ≤3). * Patients with any other medical, geographic or social condition, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Delayed hemorrhage | 15 days post-EMR |
Countries
Spain
Outcome results
None listed