Cap Assisted Colonoscopy for the Detection of Colon Polyps

NCT01211132 | Unknown

• 1 other identifier: AR0006
• Study Type: interventional
• Target: 462
• Locations: 1 country
• Sites: 1

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

Keywords

Colon polyps; Adenoma detection; Cap; Standard; Colon Cancer

Outcome Measures

Primary Outcomes (1)

• The primary outcome is the prevalence of adenomas in the two groups.

  2 years

Secondary Outcomes (1)

• 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.

  2 years

Study Arms (2)

Cap arm

ACTIVE COMPARATOR

Device: Cap - Transparent retractable extension device.

Standard arm

ACTIVE COMPARATOR

Device: Standard

Interventions

Cap - Transparent retractable extension device. DEVICE

Attaching a Cap - Transparent retractable extension device.

Also known as: Cap Assisted Colonoscopy

Cap arm

Standard DEVICE

Without attaching a transparent cap to the tip of colonoscope.

Also known as: Standard Colonoscopy

Standard arm

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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,

Sponsors & Collaborators

• American Society for Gastrointestinal Endoscopy: lead
• Midwest Biomedical Research Foundation: collaborator

Study Sites (1)

Veterans Affairs Medical Center

Kansas City, Missouri, 64128, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 21997547 DERIVED

MeSH Terms

Conditions

Adenoma; Colonic Polyps; Colonic Neoplasms; Anterior polar cataract 2

Interventions

Reference Standards

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Weights and Measures; Investigative Techniques

Study Officials

• Amit Rastogi, MD

  Veterans Affairs Medical Center, Kansas City, MO

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deepthi S Rao, MBBS

CONTACT

816-861-4700; Deepthi.Rao@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 28, 2010
• First Posted: September 29, 2010
• Study Start: September 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: November 1, 2010
• Last Updated: September 29, 2010

Record last verified: 2010-09

Locations

US (1)