Recruiting

Colonoscopy

Sponsor:

American Society for Gastrointestinal Endoscopy

Code:

NCT01211132

Conditions

Adenoma

Colon Polyps

Colon Cancer

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

Cap - Transparent retractable extension device.

Standard

Study Details

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.

Conditions

Adenoma

Colon Polyps

Colon Cancer

Study ID

NCT01211132

Start date

Sep, 2009

Status verified date

Sep, 2010

Completion date

Nov, 2010

Anticipated

Primary completion date

Oct, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

462 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Cap arm

active comparator: Standard arm

Interventions

Cap - Transparent retractable extension device.

Attaching a Cap - Transparent retractable extension device.

Standard

Without attaching a transparent cap to the tip of colonoscope.

Primary outcome measure

  • The primary outcome is the prevalence of adenomas in the two groups. [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Locations

Veterans Affairs Medical Center

Recruiting

Kansas City, Missouri, United States, 64128

Contacts

More Information

Sponsor

American Society for Gastrointestinal Endoscopy

Last update posted

Sep 29, 2010

Last verified

Sep, 2010

Keywords

  • Colon polyps
  • Adenoma detection
  • Cap
  • Standard
  • Colon Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by American Society for Gastrointestinal Endoscopy on 2010-09-29.