Trainee Participation Increases Colon Adenoma Detection Rate (ADR)

March 2, 2020 updated by: Antonio Facciorusso, Ospedali Riuniti di Foggia

Trainee Participation Increases Colon Adenoma Detection Rate: a Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background Colonoscopy is instrumental in colon cancer prevention as through polypectomy it may interfere with the adenoma-carcinoma sequence, thus resulting in a clear survival benefit.

However, not all adenomatous polyps are identified during a colonoscopy. The overall false-negative ("miss") rate for colonic adenomas is estimated to be as high as 24%, according to studies of same-day, tandem colonoscopies. In addition, flat and depressed lesions often remain undetected during white-light colonoscopy.

Low-cost optimization of existing resources, such as use of a second observer or water-aided colonoscopy, were recently found to be able to significantly increase colon adenoma detection rate (ADR).

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 (RCTs) are lacking.

.

Technical procedure In the control arm all colonoscopy will be performed by full-time board-certified gastroenterologists who have each done more than 5000 colonoscopy examinations.

In the investigation arm colonoscopy will be performed by gastroenterology fellows. The fellows will always start the case and proceed generally until they are unable to make further progress despite "coaching" from the staff attending.

During the procedures with fellows, the staff attending will always actively participate in the entire procedure and assess for the presence of any lesions.

Colonoscopies will be performed by using only high-definition white-light (HDWL) scopes (Olympus 180 series CF H180).

Bowel preparation will be uniform and consist of 4 L of polyethylene glycol. All detected lesions will be endoscopically removed and samples will be sent to pathologists for histological diagnosis.

Treatment strategy Patients complying with the eligibility criteria will be randomized in a 1:1 fashion to undergo colonoscopy performed by a trainee (under attending physician supervision) or colonoscopy performed by an experienced physician.

Sample size calculation and statistical considerations On the basis of previous retrospective comparative reports, the study is designed to detect an increase in ADR by 8%. Therefore, 812 patients (406 per arm) will be required to have a 80% power to detect the target difference at a 0.05 significance level (two sided). The primary endpoint will be ADR. In order to collect the estimated sample size, up to 1 year of recruiting will be needed.

Study Type

Interventional

Enrollment (Actual)

812

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Brindisi, Italy, 71122
        • Ospedale di Brindisi
      • Foggia, Italy, 71122
        • Ospedali Riuniti Foggia
    • Out Of USA Or Canada
      • San Severo, Out Of USA Or Canada, Italy, 71122
        • Ospedale di San Severo
      • Taranto, Out Of USA Or Canada, Italy, 71122
        • Ospedale di Taranto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients undergoing colonoscopy.

Exclusion Criteria:

  • Age under 18 years
  • Familial history of polyposis syndrome (familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer, juvenile polyposis).
  • Incomplete colonoscopy
  • Inflammatory bowel disease
  • Refusal to provide informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Trainee colonoscopy

In the investigation arm colonoscopy will be performed by gastroenterology fellows. The fellows will always start the case and proceed generally until they are unable to make further progress despite "coaching" from the staff attending.

During the procedures with fellows, the staff attending will always actively participate in the entire procedure and assess for the presence of any lesions.
Procedure: Trainee colonoscopy
Colonoscopy performed by trainee
ACTIVE_COMPARATOR: Experienced physician colonoscopy
In the control arm all colonoscopy will be performed by full-time board-certified gastroenterologists who have each done more than 5000 colonoscopy examinations.
Procedure: Experienced physician colonoscopy
Experienced physician colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adenoma detection rate
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Advanced adenoma detection rate
Time Frame: 12 months
12 months
Polyp detection rate
Time Frame: 12 months
12 months
Sessile serrated adenoma detection rate
Time Frame: 12 months
12 months
Adenoma per colonoscopy rate
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedali Riuniti di Foggia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 5, 2019

Primary Completion (ACTUAL)

December 10, 2019

Study Completion (ACTUAL)

January 10, 2020

Study Registration Dates

First Submitted

April 6, 2019

First Submitted That Met QC Criteria

April 8, 2019

First Posted (ACTUAL)

April 9, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 3, 2020

Last Update Submitted That Met QC Criteria

March 2, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADR01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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