Cap Assisted Colonoscopy for the Detection of Colon Polyps

September 28, 2010 updated by: American Society for Gastrointestinal Endoscopy

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

462

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64128
        • Recruiting
        • Veterans Affairs Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard arm
Device: Standard
Without attaching a transparent cap to the tip of colonoscope.
Other Names:
  • Standard Colonoscopy
Active Comparator: Cap arm
Device: Cap - Transparent retractable extension device.
Attaching a Cap - Transparent retractable extension device.
Other Names:
  • Cap Assisted Colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcome is the prevalence of adenomas in the two groups.
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American Society for Gastrointestinal Endoscopy

Collaborators

Midwest Biomedical Research Foundation

Investigators

  • Principal Investigator: Amit Rastogi, MD, Veterans Affairs Medical Center, Kansas City, MO

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Anticipated)

October 1, 2010

Study Completion (Anticipated)

November 1, 2010

Study Registration Dates

First Submitted

September 28, 2010

First Submitted That Met QC Criteria

September 28, 2010

First Posted (Estimate)

September 29, 2010

Study Record Updates

Last Update Posted (Estimate)

September 29, 2010

Last Update Submitted That Met QC Criteria

September 28, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AR0006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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