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Trainee Participation Increases Colon Adenoma Detection Rate (ADR)

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ClinicalTrials.gov Identifier: NCT03908229
Recruitment Status : Recruiting
First Posted : April 9, 2019
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Antonio Facciorusso, Ospedali Riuniti di Foggia

Brief 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.


Condition or disease Intervention/treatment Phase
Colonic Polyp Procedure: Trainee colonoscopy Procedure: Experienced physician colonoscopy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 812 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Trainee Participation Increases Colon Adenoma Detection Rate: a Randomized Controlled Trial
Actual Study Start Date : April 5, 2019
Estimated Primary Completion Date : December 10, 2019
Estimated Study Completion Date : January 10, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Adenoma detection rate [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Advanced adenoma detection rate [ Time Frame: 12 months ]
  2. Polyp detection rate [ Time Frame: 12 months ]
  3. Sessile serrated adenoma detection rate [ Time Frame: 12 months ]
  4. Adenoma per colonoscopy rate [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03908229


Locations
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Italy
Ospedale di San Severo Recruiting
San Severo, Out Of USA Or Canada, Italy, 71122
Contact: Marianna Di Maso, MD    0881733848    mariannadimaso@virgilio.it   
Ospedale di Taranto Recruiting
Taranto, Out Of USA Or Canada, Italy, 71122
Contact: Raffaele Licinio, MD    0881731111    jacopo.fiesco84@gmail.com   
Principal Investigator: Raffaele Licinio, MD         
Ospedale di Brindisi Recruiting
Brindisi, Italy, 71122
Contact: Viviana Neve, MD    0881732015    valedelprete80@gmail.com   
Principal Investigator: Viviana Neve, MD         
Ospedali Riuniti Foggia Recruiting
Foggia, Italy, 71122
Contact: Antonio Facciorusso, MD    0881732015    antonio.facciorusso@virgilio.it   
Sponsors and Collaborators
Ospedali Riuniti di Foggia

Publications:
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Responsible Party: Antonio Facciorusso, Assistant Professor of Gastroenterology, Ospedali Riuniti di Foggia
ClinicalTrials.gov Identifier: NCT03908229     History of Changes
Other Study ID Numbers: ADR01
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Adenoma
Colonic Polyps
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical