Clip Closure of Mucosal Defects After Endoscopic Mucosal Resection.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

235 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2018-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Endoscopic Resection Clip Haemorrhage Non-pedunculated Lesions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Clip

Clip closure of mucosal defects after endoscopic mucosal resection.

Group Type EXPERIMENTAL

Clip closure

Intervention Type DEVICE

Complete clip closure of secondary lesions after the endoscopic mucosal resection

No clip

No clip closure of mucosal defects after endoscopic mucosal resection. Observation.

Group Type ACTIVE_COMPARATOR

No clip closure

Intervention Type PROCEDURE

Observation: no clip closure of secondary lesions after the endoscopic mucosal resection

Interventions

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Clip closure

Complete clip closure of secondary lesions after the endoscopic mucosal resection

Intervention Type DEVICE

No clip closure

Observation: no clip closure of secondary lesions after the endoscopic mucosal resection

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No