Usefulness of Endocuff in the Adenoma Detection Rate. Comparative Study

Study Overview
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Brief Summary
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Colorectal cancer (CRC) is one of the leading causes of cancer death worldwide. The cumulative risk of developing CRC is about 6% lifelong. The benefit of screening colonoscopy depends on the detection and removal of all adenomas, however, some of these may be difficult to detect. The endocuff (EC) is a polymer sleeve which joins the tip of the colonoscope to improve the image viewing of the mucosa during colonoscopy procedure. There is insufficient evidence of the usefulness of endocuf

Detailed Description
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All patients requiring colonoscopy for screening and who agree to participate in the study will be included and randomized them to make an standard colonoscopy or colonoscopy with endocuff, for randomization system will be used in balanced blocks of 4, created on the page randomization.com.

Official Title
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Usefulness of Endocuff in the Adenoma Detection Rate. A Randomized Clinical Trial

Conditions
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Colorectal Canceer

Intervention / Treatment
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* Device: ENDOCUFF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult patients, Aged 18, Who would come to colonoscopy for colon cancer screening without prior colonoscopy studies Exclusion Criteria: Boston colonic preparation <5 points Suspected Lynch syndrome or familial adenomatous polyposis (FAP)

Ages Eligible for Study
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Minimum Age: 18 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: colonoscopy with endocuff<br>To the usual colonoscopy will place a endocuff at the tip of the colonoscope | Device: ENDOCUFF<br>* One endocuff device is placed at the tip of colonoscope prior to colonoscopy baseline<br>|
| No Intervention: standard colonoscopy without endocuff<br>Routine colonoscopy without endocuff | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma detection rate | Percentage of adenomas detected during colonoscopy | 30 minutes | 
| Measurement of the polyp detection rate | Percentage of polyps detected during colonoscopy | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cecal intubation rate | Percentage of cecal intubation | 30 minutes | 
| ileal intubation rate | Percentage of ileal intubation | 10 minutes | 
| Difficulty performing polypectomy | When the endoscopist requiring special maneuvers to perform polypectomy | 10 minutes | 
| Complications during colonoscopy | When patients require special handling during or immediately subsequent colonoscopy | One week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adenoma, Colonoscopy, Screening