Cap Assisted Colonoscopy for the Detection of Colon Polyps
Primary Purpose
Adenoma, Colon Polyps, Colon Cancer
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cap - Transparent retractable extension device.
Standard
Sponsored by
About this trial
This is an interventional prevention trial for Adenoma focused on measuring Colon polyps, Adenoma detection, Cap, Standard, Colon Cancer
Eligibility 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,
Sites / Locations
- Veterans Affairs Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Cap arm
Standard arm
Arm Description
Outcomes
Primary Outcome Measures
The primary outcome is the prevalence of adenomas in the two groups.
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.
Full Information
NCT ID
NCT01211132
First Posted
September 28, 2010
Last Updated
September 28, 2010
Sponsor
American Society for Gastrointestinal Endoscopy
Collaborators
Midwest Biomedical Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01211132
Brief Title
Cap Assisted Colonoscopy for the Detection of Colon Polyps
Official Title
Prospective Randomized Controlled Study of Cap Assisted Colonoscopy for the Detection of Colon Polyps
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
October 2010 (Anticipated)
Study Completion Date
November 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
American Society for Gastrointestinal Endoscopy
Collaborators
Midwest Biomedical Research Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenoma, Colon Polyps, Colon Cancer
Keywords
Colon polyps, Adenoma detection, Cap, Standard, Colon Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
462 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cap arm
Arm Type
Active Comparator
Arm Title
Standard arm
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Cap - Transparent retractable extension device.
Other Intervention Name(s)
Cap Assisted Colonoscopy
Intervention Description
Attaching a Cap - Transparent retractable extension device.
Intervention Type
Device
Intervention Name(s)
Standard
Other Intervention Name(s)
Standard Colonoscopy
Intervention Description
Without attaching a transparent cap to the tip of colonoscope.
Primary Outcome Measure Information:
Title
The primary outcome is the prevalence of adenomas in the two groups.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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,
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deepthi S Rao, MBBS
Phone
816-861-4700
Ext
56428
Email
Deepthi.Rao@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amit Rastogi, MD
Organizational Affiliation
Veterans Affairs Medical Center, Kansas City, MO
Official's Role
Principal Investigator
Facility Information:
Facility Name
Veterans Affairs Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64128
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deepthi S Rao, MBBS
Phone
816-861-4700
Ext
56428
Email
Deepthi.Rao@va.gov
12. IPD Sharing Statement
Citations:
PubMed Identifier
21997547
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.
Results Reference
derived
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Cap Assisted Colonoscopy for the Detection of Colon Polyps
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