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

NCT04636619 | Completed

• 1 other identifier: 004
• Study Type: interventional
• Target: 1,920
• Locations: 1 country
• Sites: 1

Brief 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

Colonic Polyp; Colorectal Adenoma; Colorectal Cancer

Keywords

Polypectomy,; Cold Snare polypectomy; Incomplete resection rate

Outcome Measures

Primary Outcomes (1)

• Incomplete resection rate

  To compare the change in the proportion of incomplete cold-snare polypectomies in polyps \<10mm.

  One year

Study Arms (1)

On-line training course

EXPERIMENTAL

Each participant will receive the global data, the results obtained by all the endoscopists (anonymously except for each interested party, the rest being identified by codes), as well as a detailed analysis of their results, comparing them with the joint data and the 3 tertiles.

Procedure: Colonic polypectomy; Behavioral: Online training course

Interventions

Colonic polypectomy PROCEDURE

Cold snare resection of colorectal polyps

On-line training course

Online training course BEHAVIORAL

Polypectomy technique online course

On-line training course

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years of age scheduled for a non-urgent colonoscopy.

You may not qualify if:

• Absence of lesions \<10 mm.
• Contraindication for polypectomy (anticoagulant treatment that cannot be withdrawn, treatment with clopidogrel, coagulopathy or severe thrombocytopenia)
• Loss of polypectomy specimen
• Refusal to participate

Sponsors & Collaborators

• Hospital del Rio Hortega: lead

Study Sites (1)

Hospital Rio Hortega

Valladolid, Valladolid, 47012, Spain

Location

Related Publications (14)

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MeSH Terms

Conditions

Colonic Polyps; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Marina De Benito Sanz, MD

  Hospital Río Hortega

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Patients are blinded to know which group their endoscopist belongs to. Pathology is blinded to know which group of endoscopists performed each polypectomy. A centralized research nurse, blinded to procedure and groups, will made the telephonic follow up.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Non-pharmacological clinical trial evaluating the incomplete resection rate in colonic cold snare polypectomy in two phases, before and after receiving a polypectomy online course.

Study Record Dates

• First Submitted: November 15, 2020
• First Posted: November 19, 2020
• Study Start: March 12, 2021
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)