MedDataX Logo

Cap Assisted Colonoscopy for the Detection of Colon Polyps

NCT ID: NCT01211132

Last Updated: 2010-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

462 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Adenoma Colon Polyps Colon Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Colon polyps Adenoma detection Cap Standard Colon Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cap arm

Group Type ACTIVE_COMPARATOR

Cap - Transparent retractable extension device.

Intervention Type DEVICE

Attaching a Cap - Transparent retractable extension device.

Standard arm

Group Type ACTIVE_COMPARATOR

Standard

Intervention Type DEVICE

Without attaching a transparent cap to the tip of colonoscope.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cap - Transparent retractable extension device.

Attaching a Cap - Transparent retractable extension device.

Intervention Type DEVICE

Standard

Without attaching a transparent cap to the tip of colonoscope.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Cap Assisted Colonoscopy Standard Colonoscopy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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,
Minimum Eligible Age

21 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Midwest Biomedical Research Foundation

OTHER

Sponsor Role collaborator

American Society for Gastrointestinal Endoscopy

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kansas City VA Medical Center

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Amit Rastogi, MD

Role: PRINCIPAL_INVESTIGATOR

Veterans Affairs Medical Center, Kansas City, MO

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Veterans Affairs Medical Center

Kansas City, Missouri, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Deepthi S Rao, MBBS

Role: CONTACT

Phone: 816-861-4700

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Deepthi S Rao, MBBS

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 21997547 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AR0006

Identifier Type: -

Identifier Source: org_study_id