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Trainee Participation Increases Colon Adenoma Detection Rate

NCT03908229 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 812

Last updated 2020-03-03

No results posted yet for this study

Summary

Previous studies that examined whether the presence of an additional observer, more specifically a GI fellow, during colonoscopy can enhance detection of all polyps and adenomas yielded conflicting results. Of note, all of the aforementioned studies were retrospective and robust evidence derived from well-designed randomized controlled trials are lacking.

The study objective is to examine whether fellow participation during screening, surveillance, or diagnostic colonoscopy influence overall, size-specific, or location-specific adenoma or polyp detection rate.

It will be planned to enroll 812 patients (406 per arms) within 1 year. Adenoma detection rate will be the primary outcome.

Conditions

  • Colonic Polyp

Interventions

PROCEDURE

Trainee colonoscopy

Colonoscopy performed by trainee

PROCEDURE

Experienced physician colonoscopy

Experienced physician colonoscopy

Sponsors & Collaborators

  • Ospedali Riuniti di Foggia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-05
Primary Completion
2019-12-10
Completion
2020-01-10

Countries

  • Italy

Study Locations

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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 NCT03908229 on ClinicalTrials.gov