Clinical Trial Evaluating the Effect of External Evaluation and Training on the Incomplete Resection Rate in Cold Snare Polypectomies in Colonic Lesions <10 Mm (POLIPEVA Study)

Detailed 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.

Study Details

Timeline

Interventions