Serrated Lesions Detection With Endocuff-assisted Colonoscopy - A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hospital Beatriz Ângelo
- Enrollment
- 257
- Locations
- 2
- Primary Endpoint
- Average number of serrated lesions ≥ 10 mm detected per colonoscopy
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Average number of serrated lesions ≥ 10 mm detected per colonoscopy
Time Frame: immediate
Average number of serrated lesions ≥ 10 mm detected per colonoscopy
Secondary Outcomes
- Average number of adenomas detected per colonoscopy(immediate)
- Cecal intubation rate(immediate)
- Withdrawal time(immediate)
- Incidence of procedure related adverse events(immediate)
- Average number of serrated lesions < 10 mm detected per colonoscopy(immediate)
- Serrated lesions detection rate(immediate)
- Adenoma detection rate(immediate)
- Adenocarcinoma detection rate(immediate)
- Cecal incubation time(immediate)
Investigators
Alexandre Ferreira
Dr
Hospital Beatriz Ângelo
