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

Hopital Montfort750 enrolled

Overview

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.

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?

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

750

Conditions

Colorectal Cancer Colonic Polyps

Interventions

Use of Endocuff during colonoscopyDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Hopital Montfort

Ottawa, Ontario, Canada

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 1 hour

Data from ClinicalTrials.gov

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