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
  Purpose

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.


Condition Intervention
Adenoma
Colon Polyps
Colon Cancer
Device: Cap - Transparent retractable extension device.
Device: Standard

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Prospective Randomized Controlled Study of Cap Assisted Colonoscopy for the Detection of Colon Polyps

Resource links provided by NLM:


Further study details as provided by Kansas City Veteran Affairs Medical Center:

Primary Outcome Measures:
  • The primary outcome is the prevalence of adenomas in the two groups. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 462
Study Start Date: September 2009
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cap arm Device: Cap - Transparent retractable extension device.
Attaching a Cap - Transparent retractable extension device.
Other Name: Cap Assisted Colonoscopy
Active Comparator: Standard arm Device: Standard
Without attaching a transparent cap to the tip of colonoscope.
Other Name: Standard Colonoscopy

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   21 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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,
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01211132

Contacts
Contact: Deepthi S Rao, MBBS 816-861-4700 ext 56428 Deepthi.Rao@va.gov

Locations
United States, Missouri
Veterans Affairs Medical Center Recruiting
Kansas City, Missouri, United States, 64128
Contact: Deepthi S Rao, MBBS    816-861-4700 ext 56428    Deepthi.Rao@va.gov   
Sponsors and Collaborators
American Society for Gastrointestinal Endoscopy
Midwest Biomedical Research Foundation
Investigators
Principal Investigator: Amit Rastogi, MD Veterans Affairs Medical Center, Kansas City, MO
  More Information

No publications provided by Kansas City Veteran Affairs Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amit Rastogi, MD (Prinicipal Investigator), Kansas City VA Medical Center
ClinicalTrials.gov Identifier: NCT01211132     History of Changes
Other Study ID Numbers: AR0006
Study First Received: September 28, 2010
Last Updated: September 28, 2010
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Kansas City Veteran Affairs Medical Center:
Colon polyps
Adenoma detection
Cap
Standard
Colon Cancer

Additional relevant MeSH terms:
Adenoma
Colonic Neoplasms
Colonic Polyps
Polyps
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Intestinal Polyps
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on April 23, 2014