The Utility of Cap Colonoscopy in Increasing Adenoma Detection Rate

Study Overview
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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.

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

Official Title
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The Utility of Cap Colonoscopy in Increasing Adenoma Detection Rate

Conditions
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Adenoma

Intervention / Treatment
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* Device: Cap Assisted Colonoscopy
* Device: Conventional colonoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult Hispanic patients (18-80) who are undergoing colonoscopy for screening or surveillance purposes. Exclusion Criteria: Patients younger than 18 yrs old or older than 80 yrs. Patients with a prior history of colonic surgeries Patient with Crohns colitis or ulcerative colitis. Patient with prior history of colon cancer Patient with poor bowel preparation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cap Assisted Colonoscopy<br>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. | Device: Cap Assisted Colonoscopy<br>* Plastic transparent cap added to the distal end of the colonoscope which can increase adenoma detection rate<br>|
| Active Comparator: Conventional colonoscopy<br>A conventional colonoscopy does not use a Cap in order to perform the procedure | Device: Conventional colonoscopy<br>* Regular colonoscopy as per standard clinical guidelines<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADR Differences in Hispanic Patients Undergoing a Screening Colonoscopy With and Without Cap. | 1. Compare ADR between Hispanic patients undergoing a screening colonoscopy with and without cap. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Screening colonoscopy