Cap Assisted Colonoscopy Enhances Quality Based Competency in Colonoscopy Among Trainees

Endoscopy, Gastrointestinal Clinical Trial

Official title:

Cap Assisted Colonoscopy Enhances Quality Based Competency in Colonoscopy Among Trainees

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02472730
• Other study ID #: H-36849
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: October 2015

Study information

• Verified date: January 2020
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Training novice endoscopists to perform effective diagnostic colonoscopy is a central objective of Gastroenterology fellowship. Though there is no universal definition of competency, it is traditionally assessed with a combination of objective measures such as volume of procedures and subjective factors such as formal evaluations. As quality measures such as cecal intubation time, cecal intubation rate, and adenoma detection rate gain in importance in clinical practice, they should be increasingly incorporated as objectives into more formalized and objective training methodologies.

Indeed, though 140 colonoscopies have been suggested as a rough volume threshold needed for trainees to gain competence, evidence suggests that the number may actually be much higher when taking various objective quality measures into account.

Recent attention has turned to various measures to improve trainee performance such as computer simulation and magnetic endoscopy imaging. Along these lines, simple, effective, and economical measures are needed to improve trainee performance.

Cap assisted colonoscopy (CAC) is performed with the aid of a transparent inert cap attached to the distal end of the colonoscope. CAC allows close examination of mucosa proximal to flexures and haustral folds and prevents "red out" when closely approximated against mucosa, aiding in luminal orientation and examination. CAC has been shown to improve cecal intubation time, polyp detection rate, and adenoma detection rate in the hands of experienced practitioners. A handful of studies have also indicated that these benefits also extend to trainees, while another prospective study showed no improvement in cecal intubation rate.

The investigators hypothesize that cap assisted colonoscopy will result in significantly improved cecal intubation rate and time, as well as adenoma detection rate, among trainees when compared with standard non cap assisted colonoscopy in a large academic Gastroenterology training program in the United States.

The study is a prospective randomized trial of colonoscopies performed at Harris Health System Ben Taub Hospital by all novice endoscopy trainees from July 2015 until enrollment is complete. Novice endoscopy trainees are defined as endoscopists with less than 10 colonoscopies performed by July 2015. All colonoscopies included will be performed by the novice endoscopist under direct supervision of a board certified attending gastroenterologist.

Each colonoscopy fulfilling the inclusion criteria will be randomized with equal probability to a cap assisted colonoscopy (CAC) group or a control standard colonoscopy (SC) group.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Endoscopy, Gastrointestinal

Intervention

Device:
• Distal Attachment Cap
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.

Locations

Country	Name	City	State
United States	Ben Taub Hospital	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	Alliance for Academic Internal Medicine

Country where clinical trial is conducted

United States, 

References & Publications (14)

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

Outcome

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