Comparison of Two Devices During Colonoscopy

Study Overview
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Brief Summary
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Colonoscopy is the gold standard investigation for the diagnosis of bowel pathology and colorectal cancer screening. Adenoma detection rate is a marker of high quality colonoscopy. In this study we compare two devices: Endocuff (TM) and cap that can increase the adenoma detection rate during colonoscopy.

Detailed Description
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Colonoscopy is the gold standard investigation for the diagnosis of bowel pathology and colorectal cancer screening. Adenoma detection rate is a marker of high quality colonoscopy and a high adenoma detection rate is associated with a lower incidence of interval cancers. Several technological advancements have been explored to improve adenoma detection rate. Endocuff Vision™ has been shown to improve adenoma detection rate in several studies. Cap-assisted colonoscopy is a technique that allow improved visualization of the colonic folds by flattening the fold within the viewing field. However, studies have reported mixed results on adenoma detection in cap-assisted colonoscopy. This is a prospective, single-centre, randomized controlled trial comparing the adenoma detection rate in patients undergoing Endocuff Vision™-assisted colonoscopy versus cap-assisted colonoscopy. Patients are randomized according to bowel cancer screening status to receive Endocuff Vision™-assisted colonoscopy or cap colonoscopy on the day of procedure. Baseline data, colonoscopy, and polyp data including histology are collected. Patients are followed up at 30 days for complications. This study will take place in an University Hospital in Spain. A maximum of 9 expert colonoscopists will recruit a total of 712 patients. This is the first trial to evaluate the adenoma detection rate of Endocuff Vision™ vs cap colonoscopy in all screening, surveillance, and diagnostic patient groups. This study will guide clinicians to decide what device to use to increase adenoma detection rate in routine colonoscopy

Official Title
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Endocuff vs Transparent Cap To Increase Adenoma Detection Rate During Colonoscopy

Conditions
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Adenomatous Polyps

Intervention / Treatment
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* Device: Endocuff
* Device: cap


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients who are attending for screening, surveillance or diagnostic colonoscopy. Exclusion Criteria: patients with absolute contraindications to colonoscopy; patients with established or suspicion of large bowel obstruction or pseudo-obstruction; patients with known colonic strictures; patients with a known severe diverticular segment (that is likely to impede colonoscope passage); patients with active or known colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis); patients lacking capacity to give informed consent; patients on clopidogrel, warfarin, or other new generation anticoagulants who have not stopped this for the procedure; patients who are attending for a therapeutic procedure or assessment of a known lesion, or submitted for rectoscopy or rectosigmoidoscopy; examination performed by a non-expert colonoscopist; pregnancy.

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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No

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endocuff colonoscopy<br>Endocuff-assisted colonoscopy | Device: Endocuff<br>* Endocuff-assisted colonoscopy<br>* Other names: non;|
| Active Comparator: Cap colonoscopy<br>Cap-assisted colonoscopy | Device: cap<br>* Cap-assisted colonoscopy<br>* Other names: non;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma detection rate | number of patients with at least one adenoma/total number of patients | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean adenoma per patient | total number of adenoma/total number of patient | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenoma detection rate, cap-assisted colonoscopy, endocuff