Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Alliance for Academic Internal Medicine | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cap Assisted Colonoscopy | Experimental | The distal attachment cap is affixed to the colonoscope before every colonoscopy in this arm. |
|
| Standard Colonoscopy | No Intervention | Standard colonoscopy without the distal attachment cap is performed in this arm. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Distal Attachment Cap | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kalpesh Patel, M.D. | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ben Taub Hospital | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22154419 | Background | 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. | |
| 16564908 | Background |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cap Assisted Colonoscopy | 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. |
| FG001 | Standard Colonoscopy | Standard colonoscopy without the distal attachment cap is performed in this arm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cap Assisted Colonoscopy | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Each outcome measured during a complete colonoscopy. All colonoscopies performed during the initial 3 months of a 12 month training program |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cap Assisted Colonoscopy | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kalpesh K. Patel | Baylor College of Medicine | 7137980947 | kalpeshp@bcm.edu |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| 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 |
| 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 |
| 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. |
| 1473697 | Background | 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. |
| 21514931 | Background | 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. |
| 24470280 | Background | 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. |
| 23931865 | Background | 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. |
| 22664471 | Background | 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. |
| 21997547 | Background | 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. |
| 22538693 | Background | 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. |
| 22581341 | Background | 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. |
| 21091899 | Background | 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. |
| 22042588 | Background | 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. |
| 17100978 | Background | 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. |
| 20712051 | Background | 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. |
| 28648577 | Derived | 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. |
| BG001 | Standard Colonoscopy | Standard colonoscopy without the distal attachment cap is performed in this arm. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Standard Deviation | years |
|
| Sex: Female, Male | Drop out due to clinical reasons | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Standard Colonoscopy | Standard colonoscopy without the distal attachment cap is performed in this arm. |
|
|
| 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 | Posted | Mean | 95% Confidence Interval | minutes | 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 | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | Each outcome measured during a complete colonoscopy. All colonoscopies performed during the initial 3 months of a 12 month training program |
|
|
|
| 0 |
| 101 |
| 0 |
| 101 |
| EG001 | Standard Colonoscopy | Standard colonoscopy without the distal attachment cap is performed in this arm. | 0 | 102 | 0 | 102 |
Not provided
Not provided
Not provided