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Clinical Trial Evaluating External Evaluation and Training on the Incomplete Resection (POLIPEVA Study)

NCT04636619 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1920

Last updated 2025-03-13

No results posted yet for this study

Summary

Introduction It has been shown that some quality indicators in endoscopy can be improved through educational interventions. There are marked differences in the proportion of incomplete polypectomies among endoscopists. The effectiveness of measures to improve it has not been evaluated.

Objective The main objective is to evaluate whether a training intervention or the notification of the individual proportion of incomplete polypectomies (those in which post-polypectomy biopsies of the resection margin show tissue other than normal mucosa) can improve this proportion. As secondary objectives, we will compare the proportion of fragmented polypectomies and adverse events. We will evaluate the factors associated with incomplete excision or failed cold polypectomy, as well as the individual evolution of the participants.

Methods Non-pharmacological clinical trial involving endoscopists with\> 1 year of experience and patients scheduled for colonoscopy. After each polypectomy, 2 additional biopsies will be taken and evaluated centrally by a blind pathologist. In a first phase, the basal rate of the participants will be evaluated. After it, the endoscopists will receive a course on endoscopic polypectomy and the other their rate of complete resection. The number of polyps required will vary depending on the number of endoscopists The primary objective will be compared using logistic regression models based on generalized estimating equations (GEE), taking into account the within-subject correlation.

Conditions

Interventions

PROCEDURE

Colonic polypectomy

Cold snare resection of colorectal polyps

BEHAVIORAL

Online training course

Polypectomy technique online course

Sponsors & Collaborators

  • Hospital del Rio Hortega

    lead OTHER

Principal Investigators

  • Marina De Benito Sanz, MD · Hospital Río Hortega

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-12
Primary Completion
2024-09-01
Completion
2024-12-01

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04636619 on ClinicalTrials.gov