Serrated Lesions Detection With Endocuff-assisted Colonoscopy

Hospital Beatriz Ângelo

Status: Completed

Conditions: Serrated Lesion; Adenoma; Colorectal Cancer

Treatments: Device: Endocuff colonoscopy; Device: control

Study type: Interventional

Funder types: Other

Identifiers

NCT03856957

0304

Details and patient eligibility

About

Colorectal cancer (CRC) is a leading cause of morbidity and mortality worldwide, especially in Western countries. CRC is currently considered a preventable disease and screening has been endorsed by several societies, since it has been shown that screening and surveillance are effective in reducing both CRC incidence and mortality. However, recently, concern has risen regarding colonoscopy effectiveness, especially in the right colon. The most accepted explanation for this effectiveness variability is attributed to sessile serrated lesions (SSL), which are more frequent in the proximal colon, more difficult to detect because of their flat morphology and associated with interval CRC, which is the occurrence of CRC after screening colonoscopy and before the next scheduled procedure. Several techniques are emerging to increase the sensitivity of colonoscopy for pre-cancerous lesions, especially adenomas. Recently an endoscopic cap, the Endocuff, was developed to improve adenoma detection. Several studies demonstrated improved adenoma detection with Endocuff-assisted colonoscopy when compared with conventional colonoscopy. Still, the available data for its' role in detecting SSL is very limited. The aim of this randomized controlled trial is to evaluate the effectiveness of Endocuff-assisted colonoscopy in detection of colorectal SSL.

Enrollment: 257 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Outpatients undergoing elective colonoscopies

Exclusion criteria

• Known polyposis syndromes
• Personal colorectal cancer history
• Previous colorectal surgery
• Severe diverticulosis
• Colonic stricture
• Inflammatory bowel disease
• Primary sclerosing cholangitis
• Pregnancy and breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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257 participants in 2 patient groups, including a placebo group

Endocuff colonoscopy

Experimental group

Description:

Colonoscopy performed with Endocuff

Treatment:

Device: Endocuff colonoscopy

Conventional colonoscopy

Placebo Comparator group

Description:

Colonoscopy performed without any device

Treatment:

Device: control