An interventional study of Trainee colonoscopy and Experienced physician colonoscopy in Colonic Polyp, sponsored by Ospedali Riuniti di Foggia. Completed at 4 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-03.
Sponsored by Ospedali Riuniti di Foggia · Not applicable, Interventional, and Diagnostic
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.
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.
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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.
657 studies on the registry are indexed under Adenoma; 98 are open to participants now.
This study's enrollment of 812 is above the median of 250 across 412 interventional studies indexed under Adenoma.
Browse Adenoma studies →Ospedali Riuniti di Foggia is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
Colonoscopy performed by trainee
Experienced physician colonoscopy
Adenoma detection rate
Time frame: 12 months
Advanced adenoma detection rate
Time frame: 12 months
Polyp detection rate
Time frame: 12 months
Sessile serrated adenoma detection rate
Time frame: 12 months
Adenoma per colonoscopy rate
Time frame: 12 months
Plan to share: Undecided
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Ospedali Riuniti di Foggia