Endocuff-assisted vs. Standard Colonoscopy

Study Overview
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Brief Summary
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The aim of this study is to evaluate Endocuff- assisted colonoscopy in terms of its possible additive contribution in the detection of important lesions, namely polyps and cancers, compared to standard colonoscopy, in a series of patients undergoing back-to-back screening or surveillance colonoscopies in a randomized fashion. Moreover, we aim to assess possible changes regarding post-polypectomy surveillance programs following Endocuff utilization.

Detailed Description
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Tandem colonoscopies studies results, show that novel endoscopic technologies detect about 20% more adenomas than those conventional colonoscopy does (missed adenomas). Since Endocuff-assisted colonoscopy cannot be considered as a perfect examination, we hypothesize that conventional colonoscopy will detect one third of the missed adenomas that Endocuff-assisted colonoscopy detects in a similar setting. Therefore a sample size of 120 adenomas achieves 80% power to detect an odds ratio of 3.0 using a two-sided McNemar test with a significance level of 0.05. The odds ratio is equivalent to a difference between two paired proportions of 14% which occurs when the proportion of detected missed adenomas during Endocuff-assisted colonoscopy is 21% and the proportion of missed adenomas during conventional colonoscopy is 7%. During one year period before the study initiation, our colonoscopy performance quality data show that we detect a mean number of adenomas per patient equal of 0.7 in a population similar to the one recruited in our study. Therefore, 172 patients overall will be required to detect 120 adenomas. Given the uncertainty of our estimation and in order to cope with patients exclusions, withdrawals and unexpected incomplete colonoscopies, we decided to recruit 200 patients. A more extensive description regarding the investigators study is provided in the following fields.

Official Title
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Endocuff-assisted vs. Standard Colonoscopy: a Randomized, Back-to-Back Study

Conditions
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Colon Neoplasms

Intervention / Treatment
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* Procedure: standard colonoscopy
* Procedure: Endocuff-assisted colonoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adults undergoing elective screening or surveillance colonoscopy symptomatic adults with indication for colonoscopy Exclusion Criteria: age<18 and > 80 years poor overall health (ASA III, IV) recent abdominal surgery presence of abdominal wall hernias active colitis previous bowel resection inflammatory bowel disease polyposis syndromes

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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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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standard colonoscopy<br>total polyp/adenoma detection with standard colonoscopy, polyp/adenoma detection in the right colon with standard colonoscopy | Procedure: Endocuff-assisted colonoscopy<br>* examination of the colon with Endocuff-assisted colonoscopy<br>* Other names: Endocuff;|
| Active Comparator: Endocuff-assisted colonoscopy<br>total polyp/adenoma detection with Endocuff-assisted colonoscopy, polyp/adenoma detection in the right colon with Endocuff-assisted colonoscopy | Procedure: standard colonoscopy<br>* examination of the colon with a conventional colonoscope<br>* Other names: conventional colonoscopy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number and rate of missed adenomas | in the entire colon | one week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of adenomas and adenoma detection rate in the entire colon | with both Endocuff-assisted and standard colonoscopy | one week | 
| number of adenomas and adenoma detection rate in the right colon | with both Endocuff-assisted and standard colonoscopy | one week | 
| number of polyps and polyp detection rate in the entire colon | with both Endocuff-assisted and standard colonoscopy | one week | 
| number of polyps and polyp detection rate in the right colon | with both Endocuff-assisted and standard colonoscopy | one week | 
| colonoscopy completion (colonoscopy completion rate, reason for incomplete colonoscopy) | colonoscopy completion rate, reason for incomplete colonoscopy | one week | 
| intubation and withdrawal time | for both Endocuff-assisted and standard colonoscopy (time spent for therapeutic procedures is excluded) | one week | 
| adverse events | adverse event rate | one week | 
| endoscopist's satisfaction (quantified using a scale from 0 (not satisfied) to 10 (completely satisfied) | endoscopist's satisfaction quantified using a scale from 0 (not satisfied) to 10 (completely satisfied) for Endocuff-assisted colonoscopy | one week | 
| mean number of adenomas per procedure | with both Endocuff-assisted and standard colonoscopy | one week | 

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