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

Hopital Montfort

Status: Completed

Conditions: Colonic Polyps; Colorectal Cancer

Treatments: Device: Use of Endocuff during colonoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT05615857

22-23-04-002

Details and patient eligibility

About

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.

Full description

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?

Enrollment: 750 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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750 participants in 2 patient groups

Colonoscopy without Endocuff

No Intervention group

Description:

No Endocuff inserted proximally to colonoscope and use of retroflexion

Colonoscopy with Endocuff

Experimental group

Description:

Endocuff inserted proximally to colonoscope, no use of retroflexion

Treatment:

Device: Use of Endocuff during colonoscopy