Cap Assisted Colonoscopy for the Detection of Colon Polyps

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Kansas City Veteran Affairs Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Midwest Biomedical Research Foundation
Information provided by:
Kansas City Veteran Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT01211132
First received: September 28, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted

September 28, 2010
September 28, 2010
September 2009
October 2010   (final data collection date for primary outcome measure)
The primary outcome is the prevalence of adenomas in the two groups. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
The secondary outcomes are the number of adenomas detected per subject, cecal intubation rate, insertion times, withdrawal times and complication rates in the two arms. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Cap Assisted Colonoscopy for the Detection of Colon Polyps
Prospective Randomized Controlled Study of Cap Assisted Colonoscopy for the Detection of Colon Polyps

This simple technique of attaching a transparent cap to the tip of the colonoscope has been evaluated in Japan for improving the detection of polyps and cecal intubation but has not been formally evaluated in the US and other western countries. In one study (19), the polyp detection rate was higher with the transparent cap compared to no cap (49% vs. 39%, p=0.04). Also, the cecal intubation time was shorter with the cap (11.5 min vs 14 min, p=0.008). In a recently published study, a variation of the cap called the transparent retractable extension device was used (21). Overall, the number of adenomas detected were significantly higher with the device compared to without it (205 vs. 150, p=0.04). In an earlier study by Tada et al (22), use of a transparent cap improved the detection rate of lesions per patient (0.86 vs. 0.58) but did not increase the cecal intubation time. Finally, Lee et al (20) used cap assisted colonoscopy in patients with difficult colonoscopy procedure (defined as failure to pass through sigmoid colon after 20 minutes or failure to reach cecum). Using the cap, cecal intubation was achieved in 94% of patients and this proved to be an effective rescue method for failed or difficult colonoscopy. The major appeal of this technique is that it is inexpensive, very practical, and easy to use. Furthermore it is safe and there are no reported complications from this. If found to be effective in increasing the polyp yield it has the potential to being incorporated by busy gastroenterologists in their day to day clinical practice. These features and the preliminary data from Japan merit the evaluation of this promising technique in the US.

The investigators hypothesize that adenoma detection rate will be higher using cap assisted colonoscopy compared to standard colonoscopy. Also, cap assisted colonoscopy will be safe and cecal intubation rate will be similar compared to standard colonoscopy.

Specific Aim 1 - To compare the prevalence of adenomas detected by standard colonoscopy and cap assisted colonoscopy.

Specific Aim 2 - To compare the number of adenomas detected per subject by standard colonoscopy and cap assisted colonoscopy.

Specific aim 3 - To compare the cecal intubation rate, insertion time, withdrawal time and complications of standard colonoscopy and cap assisted colonoscopy.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
  • Adenoma
  • Colon Polyps
  • Colon Cancer
  • Device: Cap - Transparent retractable extension device.
    Attaching a Cap - Transparent retractable extension device.
    Other Name: Cap Assisted Colonoscopy
  • Device: Standard
    Without attaching a transparent cap to the tip of colonoscope.
    Other Name: Standard Colonoscopy
  • Active Comparator: Cap arm
    Intervention: Device: Cap - Transparent retractable extension device.
  • Active Comparator: Standard arm
    Intervention: Device: Standard
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
462
November 2010
October 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Referral for screening and/or surveillance colonoscopy and the ability to provide informed consent.

Exclusion Criteria:

  • prior surgical resection of any portion of colon,
  • prior history of colon cancer,
  • history of inflammatory bowel disease,
  • use of anti-platelet agents or anticoagulants that precludes removal of polyps during the procedure,
  • poor general condition or any other reason to avoid prolonged procedure time
  • inability to give informed consent,
  • inadequate bowel preparation.
  • history of polyposis syndrome or HNPCC,
Both
21 Years to 85 Years
No
Contact: Deepthi S Rao, MBBS 816-861-4700 ext 56428 Deepthi.Rao@va.gov
United States
 
NCT01211132
AR0006
No
Amit Rastogi, MD (Prinicipal Investigator), Kansas City VA Medical Center
American Society for Gastrointestinal Endoscopy
Midwest Biomedical Research Foundation
Principal Investigator: Amit Rastogi, MD Veterans Affairs Medical Center, Kansas City, MO
Kansas City Veteran Affairs Medical Center
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP