Clinical trial NCT03856957: Serrated Lesions Detection With Endocuff-assisted Colonoscopy
Official title: Serrated Lesions Detection With Endocuff-assisted Colonoscopy - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Serrated Lesion
Adenoma
Colorectal Cancer
Keywords: Serrated Lesion
Endocuff
Detection
Lead sponsor: Hospital Beatriz Ângelo
Sponsor class: OTHER
First posted: 2019-02-27
Enrollment: 257
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Average number of serrated lesions ≥ 10 mm detected per colonoscopy
timeFrame: immediate
Secondary outcomes:
measure: Serrated lesions detection rate
timeFrame: immediate
measure: Average number of serrated lesions < 10 mm detected per colonoscopy
timeFrame: immediate
measure: Average number of adenomas detected per colonoscopy
timeFrame: immediate
measure: Adenoma detection rate
timeFrame: immediate
measure: Adenocarcinoma detection rate
timeFrame: immediate
measure: Cecal intubation rate
timeFrame: immediate
measure: Cecal incubation time
timeFrame: immediate
measure: Withdrawal time
timeFrame: immediate
measure: Incidence of procedure related adverse events
timeFrame: immediate
Other outcomes:
Locations:
city: Lisbon
country: Portugal
facility: Hospital Beatriz Ângelo
state: Loures
Study officials:
References: