Serrated Lesions Detection With Endocuff-assisted Colonoscopy

Study Overview
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Brief Summary
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Colorectal cancer (CRC) is a leading cause of morbidity and mortality worldwide, especially in Western countries. CRC is currently considered a preventable disease and screening has been endorsed by several societies, since it has been shown that screening and surveillance are effective in reducing both CRC incidence and mortality. However, recently, concern has risen regarding colonoscopy effectiveness, especially in the right colon. The most accepted explanation for this effectiveness variability is attributed to sessile serrated lesions (SSL), which are more frequent in the proximal colon, more difficult to detect because of their flat morphology and associated with interval CRC, which is the occurrence of CRC after screening colonoscopy and before the next scheduled procedure. Several techniques are emerging to increase the sensitivity of colonoscopy for pre-cancerous lesions, especially adenomas. Recently an endoscopic cap, the Endocuff, was developed to improve adenoma detection. Several studies demonstrated improved adenoma detection with Endocuff-assisted colonoscopy when compared with conventional colonoscopy. Still, the available data for its' role in detecting SSL is very limited. The aim of this randomized controlled trial is to evaluate the effectiveness of Endocuff-assisted colonoscopy in detection of colorectal SSL.

Official Title
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Serrated Lesions Detection With Endocuff-assisted Colonoscopy - A Randomized Controlled Trial

Conditions
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Serrated Lesion, Adenoma, Colorectal Cancer

Intervention / Treatment
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* Device: Endocuff colonoscopy
* Device: control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Outpatients undergoing elective colonoscopies Exclusion Criteria: Known polyposis syndromes Personal colorectal cancer history Previous colorectal surgery Severe diverticulosis Colonic stricture Inflammatory bowel disease Primary sclerosing cholangitis Pregnancy and breastfeeding

Ages Eligible for Study
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Minimum Age: 40 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endocuff colonoscopy<br>Colonoscopy performed with Endocuff | Device: Endocuff colonoscopy<br>* Colonoscopy performed with Endocuff for mucosal inspection and interventions (eg. polypectomy).<br>|
| Placebo Comparator: Conventional colonoscopy<br>Colonoscopy performed without any device | Device: control<br>* colonoscopy without endocuff<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average number of serrated lesions ≥ 10 mm detected per colonoscopy | Average number of serrated lesions ≥ 10 mm detected per colonoscopy | immediate | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serrated lesions detection rate | Number of patients with at least one serrated lesion/total number of participants | immediate | 
| Average number of serrated lesions < 10 mm detected per colonoscopy | Average number of serrated lesions < 10 mm detected per colonoscopy | immediate | 
| Average number of adenomas detected per colonoscopy | Average number of adenomas detected per colonoscopy | immediate | 
| Adenoma detection rate | Number of patients with at least one adenoma/total number of participants | immediate | 
| Adenocarcinoma detection rate | Number of patients with at least one adenocarcinoma/total number of participants | immediate | 
| Cecal intubation rate | Proportion of colonoscopies with cecal intubation x100 | immediate | 
| Cecal incubation time | time from the rectum to cecum in minutes | immediate | 
| Withdrawal time | time from the cecum to the rectum in minutes | immediate | 
| Incidence of procedure related adverse events | Number of adverse events | immediate | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Serrated Lesion, Endocuff, Detection