NCT02472730

Brief Summary

The purpose of this study is to identify if performing diagnostic colonoscopy with a small plastic cap attached to the camera will improve performance of colonoscopies by physician trainees.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
219

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 16, 2015

Completed
15 days until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
4.4 years until next milestone

Results Posted

Study results publicly available

February 12, 2020

Completed
Last Updated

February 12, 2020

Status Verified

January 1, 2020

Enrollment Period

2 months

First QC Date

June 12, 2015

Results QC Date

January 21, 2020

Last Update Submit

January 30, 2020

Conditions

Endoscopy, Gastrointestinal

Keywords

ColonoscopyTraining TechniquesEndoscopy, Gastrointestinal

Outcome Measures

Primary Outcomes (1)

  • Number of Participants That Successfully Reached the Cecum Within 30 Minutes of Insertion

    Proportion of all colonoscopies in which the trainee successfully reached the cecum within 30 minutes of insertion without the help of the attending physician.

    Each outcome measured during a complete colonoscopy. All colonoscopies performed during the initial 3 months of a 12 month training program

Secondary Outcomes (3)

  • Mean Time From the Moment of Colonoscope Insertion Until the Appendiceal Orifice or Ileocecal Valve is Identified

    Each outcome measured during a complete colonoscopy. All colonoscopies performed during the initial 3 months of a 12 month training program

  • Number of Colonoscopies During Which at Least One Adenoma Was Identified

    Each outcome measured during a complete colonoscopy. All colonoscopies performed during the initial 3 months of a 12 month training program

  • Number of Colonoscopies During Which at Least One Polyp Was Identified

    Each outcome measured during a complete colonoscopy. All colonoscopies performed during the initial 3 months of a 12 month training program

Study Arms (2)

Cap Assisted Colonoscopy

EXPERIMENTAL

The distal attachment cap is affixed to the colonoscope before every colonoscopy in this arm.

Device: Distal Attachment Cap

Standard Colonoscopy

NO INTERVENTION

Standard colonoscopy without the distal attachment cap is performed in this arm.

Interventions

Distal Attachment CapDEVICE

Colonoscopies are performed under the supervision of board certified attending gastroenterologists experienced in colonoscopy. Attending physicians will provide assistance at their discretion or at the request of the trainee. All close examinations for polyps will be carried out on withdrawal of the colonoscope.

Also known as: US Endoscopy Distal Attachment Cap
Cap Assisted Colonoscopy

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients undergoing colonoscopy by a novice endoscopist

You may not qualify if:

  • Age less than 18 years or greater than 90 years.
  • Pregnancy.
  • Prior surgical resection of colon or rectum.
  • Known obstructing colorectal tumors.
  • Severe hematochezia.
  • Diverticulitis within 1 month of procedure.
  • Clinical or radiological evidence of colonic obstruction or megacolon within 1 month of procedure.
  • Referral for endoscopic mucosal resection.
  • Unsedated colonoscopies.
  • Colonoscopies abandoned due to inadequate bowel prep or colonoscopies with Boston bowel prep score \< 3.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ben Taub Hospital

Houston, Texas, 77030, United States

Location

Related Publications (15)

  • ASGE Training Committee; Adler DG, Bakis G, Coyle WJ, DeGregorio B, Dua KS, Lee LS, McHenry L Jr, Pais SA, Rajan E, Sedlack RE, Shami VM, Faulx AL. Principles of training in GI endoscopy. Gastrointest Endosc. 2012 Feb;75(2):231-5. doi: 10.1016/j.gie.2011.09.008. Epub 2011 Dec 7. No abstract available.

    PMID: 22154419BACKGROUND

  • Rex DK, Petrini JL, Baron TH, Chak A, Cohen J, Deal SE, Hoffman B, Jacobson BC, Mergener K, Petersen BT, Safdi MA, Faigel DO, Pike IM. Quality indicators for colonoscopy. Gastrointest Endosc. 2006 Apr;63(4 Suppl):S16-28. doi: 10.1016/j.gie.2006.02.021. No abstract available.

    PMID: 16564908BACKGROUND

  • Vennes JA, Ament M, Boyce HW Jr, Cotton PB, Jensen DM, Ravich WJ, Sugawa C, Wu WC, Sanowski RA, Ament M, et al. Principles of training in gastrointestinal endoscopy. American Society for Gastrointestinal Endoscopy. Standards of Training Committees. 1989-1990. Gastrointest Endosc. 1992 Nov-Dec;38(6):743-6. No abstract available.

    PMID: 1473697BACKGROUND

  • Sedlack RE. Training to competency in colonoscopy: assessing and defining competency standards. Gastrointest Endosc. 2011 Aug;74(2):355-366.e1-2. doi: 10.1016/j.gie.2011.02.019. Epub 2011 Apr 23.

    PMID: 21514931BACKGROUND

  • Ward ST, Mohammed MA, Walt R, Valori R, Ismail T, Dunckley P. An analysis of the learning curve to achieve competency at colonoscopy using the JETS database. Gut. 2014 Nov;63(11):1746-54. doi: 10.1136/gutjnl-2013-305973. Epub 2014 Jan 27.

    PMID: 24470280BACKGROUND

  • Gomez V, Wallace MB. Training and teaching innovations in colonoscopy. Gastroenterol Clin North Am. 2013 Sep;42(3):659-70. doi: 10.1016/j.gtc.2013.05.001.

    PMID: 23931865BACKGROUND

  • Ng SC, Tsoi KK, Hirai HW, Lee YT, Wu JC, Sung JJ, Chan FK, Lau JY. The efficacy of cap-assisted colonoscopy in polyp detection and cecal intubation: a meta-analysis of randomized controlled trials. Am J Gastroenterol. 2012 Aug;107(8):1165-73. doi: 10.1038/ajg.2012.135. Epub 2012 Jun 5.

    PMID: 22664471BACKGROUND

  • Rastogi A, Bansal A, Rao DS, Gupta N, Wani SB, Shipe T, Gaddam S, Singh V, Sharma P. Higher adenoma detection rates with cap-assisted colonoscopy: a randomised controlled trial. Gut. 2012 Mar;61(3):402-8. doi: 10.1136/gutjnl-2011-300187. Epub 2011 Oct 13.

    PMID: 21997547BACKGROUND

  • Park SM, Lee SH, Shin KY, Heo J, Sung SH, Park SH, Choi SY, Lee DW, Park HG, Lee HS, Jeon SW, Kim SK, Jung MK. The cap-assisted technique enhances colonoscopy training: prospective randomized study of six trainees. Surg Endosc. 2012 Oct;26(10):2939-43. doi: 10.1007/s00464-012-2288-2. Epub 2012 Apr 27.

    PMID: 22538693BACKGROUND

  • Manta R, Mangiavillano B, Fedeli P, Viaggi P, Castellani D, Conigliaro R, Masci E, Bassotti G. Hood colonoscopy in trainees: a useful adjunct to improve the performance. Dig Dis Sci. 2012 Oct;57(10):2675-9. doi: 10.1007/s10620-012-2213-5. Epub 2012 May 13.

    PMID: 22581341BACKGROUND

  • Dai J, Feng N, Lu H, Li XB, Yang CH, Ge ZZ. Transparent cap improves patients' tolerance of colonoscopy and shortens examination time by inexperienced endoscopists. J Dig Dis. 2010 Dec;11(6):364-8. doi: 10.1111/j.1751-2980.2010.00460.x.

    PMID: 21091899BACKGROUND

  • Prachayakul V, Aswakul P, Limsrivilai J, Anuchapreeda S, Bhanthumkomol P, Sripongpun P, Prangboonyarat T, Kachintorn U. Benefit of "transparent soft-short-hood on the scope" for colonoscopy among experienced gastroenterologists and gastroenterologist trainee: a randomized, controlled trial. Surg Endosc. 2012 Apr;26(4):1041-6. doi: 10.1007/s00464-011-1992-7. Epub 2011 Nov 1.

    PMID: 22042588BACKGROUND

  • Kondo S, Yamaji Y, Watabe H, Yamada A, Sugimoto T, Ohta M, Ogura K, Okamoto M, Yoshida H, Kawabe T, Omata M. A randomized controlled trial evaluating the usefulness of a transparent hood attached to the tip of the colonoscope. Am J Gastroenterol. 2007 Jan;102(1):75-81. doi: 10.1111/j.1572-0241.2006.00897.x. Epub 2006 Nov 13.

    PMID: 17100978BACKGROUND

  • Tee HP, Corte C, Al-Ghamdi H, Prakoso E, Darke J, Chettiar R, Rahman W, Davison S, Griffin SP, Selby WS, Kaffes AJ. Prospective randomized controlled trial evaluating cap-assisted colonoscopy vs standard colonoscopy. World J Gastroenterol. 2010 Aug 21;16(31):3905-10. doi: 10.3748/wjg.v16.i31.3905.

    PMID: 20712051BACKGROUND

  • Tang Z, Zhang DS, Thrift AP, Patel KK. Impact of cap-assisted colonoscopy on the learning curve and quality in colonoscopy: a randomized controlled trial. Gastrointest Endosc. 2018 Mar;87(3):723-732.e3. doi: 10.1016/j.gie.2017.06.011. Epub 2017 Jun 23.

    PMID: 28648577DERIVED

Results Point of Contact

Title
Dr. Kalpesh K. Patel
Organization
Baylor College of Medicine
kalpeshp@bcm.edu
7137980947

Study Officials

  • Kalpesh Patel, M.D.

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

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

Study Record Dates

First Submitted

June 12, 2015

First Posted

June 16, 2015

Study Start

July 1, 2015

Primary Completion

September 1, 2015

Study Completion

October 1, 2015

Last Updated

February 12, 2020

Results First Posted

February 12, 2020

Record last verified: 2020-01

Locations

US(1)