Endocuff Enhanced Colonoscopy: Does it Improve Polyp Detection and Make Rectal Retroflexion Unnecessary

Study Overview
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Brief Summary
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The investigators hope that this project will determine if the Endocuff device is a useful adjunct during colonoscopy by optimizing polyp detection and eliminating the need for the painful rectal retroflexion. As such, by improving polyp detection and eliminating the need for rectal retroflexion, it will directly reduce the likelihood of colon cancer and improve patient comfort respectively.

Detailed Description
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Every day, 73 Canadians are diagnosed with colorectal cancer. This cancer is the third most diagnosed type of cancer in Canada while being the second and third most deadly cancer for men and women respectively. In addition, it accounts for 12% of all cancer diagnoses and cancer deaths for both sexes in 2020. Fortunately, colorectal cancer incidence and mortality rates have been steadily declining in the recent years. This can be attributed to the development of new screening methods and devices assisting in a more reliable identification of polyps as well as removal during colonoscopy. This is essential to prevent cancer as these usually asymptomatic and harmless clusters of atypical cells can turn into cancers, and become fatal if they can progress to a later stage of their development. The Endocuff is a new colonoscopy assisting device designed to aid physicians to maneuver inside the colon, allowing for increased detection of polyps that stay hidden between folds in the colon. By its flexible and hinged arms, the Endocuff is designed to gently flatten the large colonic folds during withdrawal of the colonoscope, bringing the difficult-to-see mucosa to view. The Endocuff also may assist in the view of the rectum, being the last area of the colon and difficult to assess. Usually, a painful procedure called a retroflexion is used to help see this area. However, this pain can limit the evaluation and impact polyp diagnosis in the rectum. In this study, the investigators aspire to answer these following questions: (1) Can the Endocuff improve polyp detection? (2) Can the Endocuff replace the need for retroflexion in the rectum?

Official Title
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Endocuff Enhanced Colonoscopy: Does it Improve Polyp Detection and Make Rectal Retroflexion Unnecessary

Conditions
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Colorectal Cancer, Colonic Polyps

Intervention / Treatment
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* Device: Use of Endocuff during colonoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any patient undergoing a colonoscopy during the study period Procedure being performed by a gastroenterologist (i.e., surgeons are excluded) Exclusion Criteria: Inflammatory Bowel Disease Hereditary Mixed Polyposis Syndrome Diverticulitis Colonic stricture Toxic Megacolon Previous Colon surgery, excluding appendectomy Radiation therapy to abdomen or pelvis Pregnancy/Lactation Anticoagulant use Suffered stroke or ischemia in previous 3 months Being deemed too risky by investigator FIT positive Poor preparation

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: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: We are to count the number of adenomas and polyps identified per patient while using the Endocuff. These numbers will be compared to the number of identified adenomas and polyps found without the use of the Endocuff retrospectively. In addition, the number of adenomas and polyps found in the rectum while using the Endocuff will be compared to the numbers of adenomas and polyps found with retroflexion without the use of Endocuff. Once the colonoscopy is complete, the patient's level of comfort during the procedure will be documented.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Colonoscopy without Endocuff<br>No Endocuff inserted proximally to colonoscope and use of retroflexion | |
| Experimental: Colonoscopy with Endocuff<br>Endocuff inserted proximally to colonoscope, no use of retroflexion | Device: Use of Endocuff during colonoscopy<br>* We will be adding the Endocuff device to the proximal end of the colonoscope, adding an additional tool to facilitate the visualization of the difficult-to-see mucosal areas as well as the rectum. There will be no need for retroflexion to evaluate the colon<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in Polyp Detection Rates when using the Endocuff Enhanced Colonoscopy. | Comparing Polyp Detection Rate when using the Endocuff Enhanced Colonoscopy to retrospective conventional colonoscopy. | 1 hour | 
| Number of participants endorsing a comfortable procedure when using the Endocuff assisted colonoscopy assessed by Numerical Rating Scale (NRS). | Results of Numerical Rating Scale pain score when evaluating the rectum with the Endocuff. | 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Retroflexion, Colonoscopy, Endocuff, Polyp detection, Screening