Clinical trial NCT05615857: Endocuff Enhanced Colonoscopy: Does it Improve Polyp Detection and Make Rectal Retroflexion Unnecessary
Official title: Endocuff Enhanced Colonoscopy: Does it Improve Polyp Detection and Make Rectal Retroflexion Unnecessary
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Colonic Polyps
Keywords: Endocuff
Retroflexion
Colonoscopy
Polyp detection
Screening
Lead sponsor: Hopital Montfort
Sponsor class: OTHER
Collaborators: name: AFP Innovation Fund
First posted: 2022-11-14
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SCREENING

Brief summary: 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: 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?

Eligibility criteria: 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

Primary outcomes:
measure: Increase in Polyp Detection Rates when using the Endocuff Enhanced Colonoscopy.
timeFrame: 1 hour
measure: Number of participants endorsing a comfortable procedure when using the Endocuff assisted colonoscopy assessed by Numerical Rating Scale (NRS).
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Hopital Montfort
state: Ontario
Study officials:
affiliation: Hopital Montfort
name: Philip Hassard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital Montfort
name: Christine-Nadia Compas, CRC
role: STUDY_DIRECTOR
References: