The Utility of Cap Colonoscopy in Increasing Adenoma Detection Rate

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

440 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-29

Study Completion Date

2015-02-02

Brief Summary

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This is a research study about the usefulness of transparent cap during screening colonoscopy. The purpose of the research is to test the usefulness of adding small cap to the tip of the colonoscope. the investigators hypothesis is that Cap assisted colonoscopy will improve the detection of adenomatous polyps (polyps which can become colon cancer later on) in comparison to the standard colonoscopy.

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Detailed Description

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This is a prospective, randomized trial comparing the adenoma detection rate between Hispanic patients undergoing a screening colonoscopy with a conventional colonoscope or with a cap-assisted colonoscopy. The aims of the study are:

1. Compare ADR between Hispanic patients undergoing a screening colonoscopy with and without cap.
2. Compare the overall polyp detection rate between Hispanic patients undergoing a screening colonoscopy with and without cap.
3. Compare the cecal intubation rate and cecal intubation time between standard colonoscopy and cap assisted colonoscopy.
4. Compare the complication rate between standard colonoscopy and cap assisted colonoscopy.

Conditions

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Adenoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Cap Assisted Colonoscopy

Cap Assisted Colonoscopy uses a Cap which is a transparent hood which is attached to the distal end of the colonscope and allows depressing the colon folds in order to visualize hidden polyps behind the folds.

Group Type EXPERIMENTAL

Cap Assisted Colonoscopy

Intervention Type DEVICE

Plastic transparent cap added to the distal end of the colonoscope which can increase adenoma detection rate

Conventional colonoscopy

A conventional colonoscopy does not use a Cap in order to perform the procedure

Group Type ACTIVE_COMPARATOR

Conventional colonoscopy

Intervention Type DEVICE

Regular colonoscopy as per standard clinical guidelines

Interventions

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Cap Assisted Colonoscopy

Plastic transparent cap added to the distal end of the colonoscope which can increase adenoma detection rate

Intervention Type DEVICE

Conventional colonoscopy

Regular colonoscopy as per standard clinical guidelines

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adult Hispanic patients (18-80) who are undergoing colonoscopy for screening or surveillance purposes.

Exclusion Criteria

1. Patients younger than 18 yrs old or older than 80 yrs.
2. Patients with a prior history of colonic surgeries
3. Patient with Crohns colitis or ulcerative colitis.
4. Patient with prior history of colon cancer
5. Patient with poor bowel preparation

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes