Endoscopy, Gastrointestinal Clinical Trial
Official title:
Cap Assisted Colonoscopy Enhances Quality Based Competency in Colonoscopy Among Trainees
NCT number | NCT02472730 |
Other study ID # | H-36849 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2015 |
Est. completion date | October 2015 |
Verified date | January 2020 |
Source | Baylor College of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 219 |
Est. completion date | October 2015 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - All patients undergoing colonoscopy by a novice endoscopist Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Ben Taub Hospital | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Baylor College of Medicine | Alliance for Academic Internal Medicine |
United States,
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. — View Citation
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. — View Citation
Gómez 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. Review. — View Citation
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. Epub 2006 Nov 13. — View Citation
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. Epub 2012 May 13. — View Citation
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. Review. — View Citation
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. Epub 2012 Apr 27. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
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. Erratum in: Gastrointest Endosc. 2011 Sep;74(3):729. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Mean Time From the Moment of Colonoscope Insertion Until the Appendiceal Orifice or Ileocecal Valve is Identified | 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 | |
Secondary | Number of Colonoscopies During Which at Least One Adenoma Was Identified | Proportion of colonoscopies that identify at least one adenoma | Each outcome measured during a complete colonoscopy. All colonoscopies performed during the initial 3 months of a 12 month training program | |
Secondary | Number of Colonoscopies During Which at Least One Polyp Was Identified | Proportion of colonoscopies that identify at least one polyp | Each outcome measured during a complete colonoscopy. All colonoscopies performed during the initial 3 months of a 12 month training program |
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