Endo-cuff Assisted Vs. Standard Colonoscopy for Polyp Detection in Bowel Cancer Screening

Study Overview
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Brief Summary
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The study evaluates whether the use of a novel endoscopic cap (the endo-cuff) at the tip of a colonoscope improves the numbers of polyps detected during bowel cancer screening colonoscopy. Half the patients will have standard colonoscopy and half will have colonoscopy with the cap attached.

Detailed Description
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Problem statement: In England, everyone in the age group of 60-69 years is invited to participate in bowel cancer screening. Those who test positive in the initial screening stool test are invited to have a colonoscopy. The purpose of colonoscopy is to detect any obvious cancers, and in the absence of obvious cancers the purpose is to detect and remove all the polyps present in the colon, as polyps have the potential to develop into cancers. However, colonoscopy still misses up to 25% of polyps. Cap assisted colonoscopy improves polyp detection but still misses a significant number of polyps. There is a need for an improved cap design which will help improve polyp detection. Research question/hypothesis: Does using an endocuff on a colonoscope improve polyp detection as compared to standard colonoscopy in bowel cancer screening patients? Study design: Parallel group, single blinded randomised controlled trial Study participants: Patients attending for colonoscopy under the bowel cancer screening programme Planned sample size: 534 Planned study period: 12 months Primary objective: To assess the impact of endocuff assisted colonoscopy on the number of polyps detected per patient

Official Title
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Endo-cuff Assisted Colonoscopy Versus Standard Colonoscopy for Polyp Detection in Bowel Cancer Screening Patients: A Randomised Controlled Trial. The E-CAP Study

Conditions
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Colonic Polyps, Colonic Neoplasms

Intervention / Treatment
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* Device: Endo-cuff
* Other: Standard colonoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients referred for colonoscopy under the national bowel cancer screening programme Able to provide written informed consent Exclusion Criteria: History of Inflammatory bowel disease History of Hereditary non polyposis colorectal cancer

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 75 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: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard<br>These patients have standard colonoscopy performed | Other: Standard colonoscopy<br>* Standard colonoscopy without end-cuff<br>|
| Experimental: Endocuff<br>These patients have colonoscopy performed with the endo-cuff attached to the end of the colonoscope | Device: Endo-cuff<br>* Colonoscopy performed with endo-cuff attached to the colonoscope<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of polyps detected per patient |  | 1 month (when pathology report available) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer detection rate |  | 1 month (when pathology report available) | 
| Polyp detection rate |  | 1 month (when pathology report available) | 
| Adenomas per patient |  | 1 month (when pathology report available) | 
| Adenoma detection rate |  | 1 month (when pathology report available) | 
| Caecal intubation rate | will be recorded at the time of the procedure | 1 day | 
| Total procedure time - from scope insertion to removal | will be recorded at the time of the procedure | 1 day | 
| Time taken to reach caecum | will be recorded at the time of the procedure | 1 day | 
| Time taken to withdraw scope (from caecum to removal of scope) | will be recorded at the time of the procedure | 1 day | 
| Patient comfort score | will be recorded at the time of the procedure | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonoscopy, early cancer detection, cancer screening