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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02876133
Date of registration:	18/08/2016
Prospective Registration:	Yes
Primary sponsor:	Hospital Beatriz Ângelo
Public title:	Narrow Band Imaging Versus White Light for Colonoscopy Serrate Lesions Detection
Scientific title:	Improving Colorectal Cancer Screening: Using Narrow Band Imaging for Colonic Sessile Serrated Lesions
Date of first enrolment:	November 2016
Target sample size:	987
Recruitment status:	Unknown status
URL:	https://clinicaltrials.gov/show/NCT02876133
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
Phase:	N/A

Countries of recruitment
Portugal

Contacts

Name:	Alexandre O Ferreira, MD
Address:
Telephone:
Email:	alex.gastrohep@gmail.com
Affiliation:

Name:	Alexandre O Ferreira, MD
Address:
Telephone:
Email:
Affiliation:	Hospital Beatriz Ângelo

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients scheduled for elective colonoscopies

Exclusion Criteria:

- known polyposis syndromes

- primary sclerosing cholangitis

- inflammatory bowel disease

- personal colorectal cancer history

Age minimum: 40 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Colon Cancer

Colon Sessile Serrated Adenoma/Polyp

Intervention(s)

Device: white light withdrawal

Device: narrow band imaging withdrawal

Primary Outcome(s)

average number of serrated lesions =10 mm detected per colonoscopy [Time Frame: immediate]

Secondary Outcome(s)

SSL detection rate [Time Frame: immediate]

Serrated class lesions detection rate [Time Frame: immediate]

Advanced (malignant) adenocarcinoma detection rate [Time Frame: immediate]

Adenoma detection rate [Time Frame: immediate]

Adenomas detected per colonoscopy [Time Frame: immediate]

Incidence of procedure related adverse events [Time Frame: immediate]

Serrated lesions <10 mm detected per colonoscopy [Time Frame: immediate]

Secondary ID(s)

176

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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