Cap Assisted Colonoscopy Enhances Quality Based Competency in Colonoscopy Among Trainees

• Sponsor: Baylor College of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT02472730
• Collaborator: Alliance for Academic Internal Medicine (Other)
• Enrollment: 219
• Location: 1
• Arms: 2
• Duration (Months): 3
• Patients Per Site Per Month: 72.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endoscopy, Gastrointestinal	Device: Distal Attachment Cap	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 219 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Cap Assisted Colonoscopy Enhances Quality Based Competency in Colonoscopy Among Trainees
• Study Start Date: Jul 1, 2015
• Actual Primary Completion Date: Sep 1, 2015
• Actual Study Completion Date: Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cap Assisted Colonoscopy The distal attachment cap is affixed to the colonoscope before every colonoscopy in this arm.	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.; Other Names: US Endoscopy Distal Attachment Cap
No Intervention: Standard Colonoscopy Standard colonoscopy without the distal attachment cap is performed in this arm.

Outcome Measures

Primary Outcome Measures

1. Number of Participants That Successfully Reached the Cecum Within 30 Minutes of Insertion [Each outcome measured during a complete colonoscopy. All colonoscopies performed during the initial 3 months of a 12 month training program]

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

Secondary Outcome Measures

1. 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]

   Time from the moment of colonoscope insertion until the appendiceal orifice or ileocecal valve is identified

2. 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]

   Proportion of colonoscopies that identify at least one adenoma

3. 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]

   Proportion of colonoscopies that identify at least one polyp

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ben Taub Hospital	Houston	Texas	United States	77030

Sponsors and Collaborators

• Baylor College of Medicine
• Alliance for Academic Internal Medicine

Investigators

• Principal Investigator: Kalpesh Patel, M.D., Baylor College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Kalpesh Patel, Assistant Professor, Baylor College of Medicine
• ClinicalTrials.gov Identifier: NCT02472730
• Other Study ID Numbers: H-36849
• First Posted: Jun 16, 2015
• Last Update Posted: Feb 12, 2020
• Last Verified: Jan 1, 2020

• Keywords provided by Kalpesh Patel, Assistant Professor, Baylor College of Medicine: Colonoscopy; Training Techniques; Endoscopy, Gastrointestinal

Study Results

Participant Flow

Arm/Group Title	Cap Assisted Colonoscopy	Standard Colonoscopy
Arm/Group Description	The distal attachment cap is affixed to the colonoscope before every colonoscopy in this arm. 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.	Standard colonoscopy without the distal attachment cap is performed in this arm.
Period Title: Overall Study
STARTED	110	109
COMPLETED	101	102
NOT COMPLETED	9	7

Baseline Characteristics

Arm/Group Title	Cap Assisted Colonoscopy	Standard Colonoscopy	Total
Arm/Group Description	The distal attachment cap is affixed to the colonoscope before every colonoscopy in this arm. 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.	Standard colonoscopy without the distal attachment cap is performed in this arm.	Total of all reporting groups
Overall Participants	110	109	219
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	90 81.8%	92 84.4%	182 83.1%
>=65 years	20 18.2%	017 15.6%	37 16.9%
Age (years) [Median (Standard Deviation) ]
Median (Standard Deviation) [years]	55.6 (8.84)	55.8 (9.39)	55.7 (9.09)
Sex: Female, Male (Count of Participants)
Female	78 70.9%	69 63.3%	147 67.1%
Male	32 29.1%	40 36.7%	72 32.9%
Region of Enrollment (Count of Participants)
United States	110 100%	109 100%	219 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants That Successfully Reached the Cecum Within 30 Minutes of Insertion
Description	Proportion of all colonoscopies in which the trainee successfully reached the cecum within 30 minutes of insertion without the help of the attending physician.
Time Frame	Each outcome measured during a complete colonoscopy. All colonoscopies performed during the initial 3 months of a 12 month training program

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cap Assisted Colonoscopy	Standard Colonoscopy
Arm/Group Description	The distal attachment cap is affixed to the colonoscope before every colonoscopy in this arm. 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.	Standard colonoscopy without the distal attachment cap is performed in this arm.
Measure Participants	101	102
Count of Participants [Participants]	80 72.7%	67 61.5%

2. Secondary Outcome

Title	Mean Time From the Moment of Colonoscope Insertion Until the Appendiceal Orifice or Ileocecal Valve is Identified
Description	Time from the moment of colonoscope insertion until the appendiceal orifice or ileocecal valve is identified
Time Frame	Each outcome measured during a complete colonoscopy. All colonoscopies performed during the initial 3 months of a 12 month training program

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cap Assisted Colonoscopy	Standard Colonoscopy
Arm/Group Description	The distal attachment cap is affixed to the colonoscope before every colonoscopy in this arm. 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.	Standard colonoscopy without the distal attachment cap is performed in this arm.
Measure Participants	101	102
Mean (95% Confidence Interval) [minutes]	13.7	16.5

3. Secondary Outcome

Title	Number of Colonoscopies During Which at Least One Adenoma Was Identified
Description	Proportion of colonoscopies that identify at least one adenoma
Time Frame	Each outcome measured during a complete colonoscopy. All colonoscopies performed during the initial 3 months of a 12 month training program

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cap Assisted Colonoscopy	Standard Colonoscopy
Arm/Group Description	The distal attachment cap is affixed to the colonoscope before every colonoscopy in this arm. 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.	Standard colonoscopy without the distal attachment cap is performed in this arm.
Measure Participants	101	102
Count of Participants [Participants]	38 34.5%	44 40.4%

4. Secondary Outcome

Title	Number of Colonoscopies During Which at Least One Polyp Was Identified
Description	Proportion of colonoscopies that identify at least one polyp
Time Frame	Each outcome measured during a complete colonoscopy. All colonoscopies performed during the initial 3 months of a 12 month training program

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cap Assisted Colonoscopy	Standard Colonoscopy
Arm/Group Description	The distal attachment cap is affixed to the colonoscope before every colonoscopy in this arm. 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.	Standard colonoscopy without the distal attachment cap is performed in this arm.
Measure Participants	101	102
Count of Participants [Participants]	54 49.1%	55 50.5%

Adverse Events

Arm/Group Title	Cap Assisted Colonoscopy		Standard Colonoscopy
Arm/Group Description	The distal attachment cap is affixed to the colonoscope before every colonoscopy in this arm. 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.		Standard colonoscopy without the distal attachment cap is performed in this arm.
All Cause Mortality
	Cap Assisted Colonoscopy		Standard Colonoscopy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Cap Assisted Colonoscopy		Standard Colonoscopy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/101 (0%)		0/102 (0%)
Other (Not Including Serious) Adverse Events
	Cap Assisted Colonoscopy		Standard Colonoscopy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/101 (0%)		0/102 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.