Trainee Participation Increases Colon Adenoma Detection Rate

NCT03908229 | Completed

• 1 other identifier: ADR01
• Study Type: interventional
• Target: 812
• Locations: 1 country
• Sites: 4

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.

Conditions

Colonic Polyp

Outcome Measures

Primary Outcomes (1)

• Adenoma detection rate

  12 months

Secondary Outcomes (4)

• Advanced adenoma detection rate

  12 months

• Polyp detection rate

  12 months

• Sessile serrated adenoma detection rate

  12 months

• Adenoma per colonoscopy rate

  12 months

Study Arms (2)

Trainee colonoscopy

EXPERIMENTAL

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

Experienced physician colonoscopy

ACTIVE COMPARATOR

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

Interventions

Trainee colonoscopy PROCEDURE

Colonoscopy performed by trainee

Trainee colonoscopy

Experienced physician colonoscopy PROCEDURE

Experienced physician colonoscopy

Experienced physician colonoscopy

Eligibility Criteria

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

You may qualify if:

• Adult patients undergoing colonoscopy.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ospedali Riuniti di Foggia: lead

Study Sites (4)

Ospedale di San Severo

San Severo, Out of USA Or Canada, 71122, Italy

Location

Ospedale di Taranto

Taranto, Out of USA Or Canada, 71122, Italy

Location

Ospedale di Brindisi

Brindisi, 71122, Italy

Location

Ospedali Riuniti Foggia

Foggia, 71122, Italy

Location

Related Publications (7)

• Rex DK, Chadalawada V, Helper DJ. Wide angle colonoscopy with a prototype instrument: impact on miss rates and efficiency as determined by back-to-back colonoscopies. Am J Gastroenterol. 2003 Sep;98(9):2000-5. doi: 10.1111/j.1572-0241.2003.07662.x.

  PMID: 14499778 BACKGROUND

• Rex DK. Maximizing detection of adenomas and cancers during colonoscopy. Am J Gastroenterol. 2006 Dec;101(12):2866-77. doi: 10.1111/j.1572-0241.2006.00905.x.

  PMID: 17227527 BACKGROUND

• Facciorusso A, Triantafyllou K, Murad MH, Prokop LJ, Tziatzios G, Muscatiello N, Singh S. Compared Abilities of Endoscopic Techniques to Increase Colon Adenoma Detection Rates: A Network Meta-analysis. Clin Gastroenterol Hepatol. 2019 Nov;17(12):2439-2454.e25. doi: 10.1016/j.cgh.2018.11.058. Epub 2018 Dec 6.

  PMID: 30529731 BACKGROUND

• Gianotti RJ, Oza SS, Tapper EB, Kothari D, Sheth SG. A Longitudinal Study of Adenoma Detection Rate in Gastroenterology Fellowship Training. Dig Dis Sci. 2016 Oct;61(10):2831-2837. doi: 10.1007/s10620-016-4228-9. Epub 2016 Jul 12.

  PMID: 27405989 BACKGROUND

• Nishizawa T, Suzuki H, Takahashi M, Kaneko H, Fujiyama Y, Komatsu H, Nagumo H, Tanaka S, Hibi T. Trainee participation during colonoscopy adversely affects polyp and adenoma detection rates. Digestion. 2011;84(3):245-6. doi: 10.1159/000330736. Epub 2011 Sep 7. No abstract available.

  PMID: 21912131 BACKGROUND

• Buchner AM, Shahid MW, Heckman MG, Diehl NN, McNeil RB, Cleveland P, Gill KR, Schore A, Ghabril M, Raimondo M, Gross SA, Wallace MB. Trainee participation is associated with increased small adenoma detection. Gastrointest Endosc. 2011 Jun;73(6):1223-31. doi: 10.1016/j.gie.2011.01.060. Epub 2011 Apr 8.

  PMID: 21481861 BACKGROUND

• Facciorusso A, Buccino VR, Tonti P, Licinio R, Del Prete V, Neve V, Di Maso M, Muscatiello N. Impact of fellow participation on colon adenoma detection rates: a multicenter randomized trial. Gastrointest Endosc. 2020 Dec;92(6):1228-1235. doi: 10.1016/j.gie.2020.05.015. Epub 2020 May 17.

  PMID: 32433915 DERIVED

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Gastroenterology

Study Record Dates

• First Submitted: April 6, 2019
• First Posted: April 9, 2019
• Study Start: April 5, 2019
• Primary Completion: December 10, 2019
• Study Completion: January 10, 2020
• Last Updated: March 3, 2020

Record last verified: 2020-03

Locations

IT (4)