Randomised controlled trial of narrow band imaging (NBI) versus standard endoscopy for adenoma detection

ISRCTN	ISRCTN36386665
DOI	https://doi.org/10.1186/ISRCTN36386665
Secondary identifying numbers	N0515176146

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Brian P Saunders
Scientific

The Wolfson Unit 2nd Floor
North West London Hospitals NHS Trust
St Mark's Hospital
Watford Road
Harrow
HA1 3UJ
United Kingdom

Phone	+44 (0)20 8235 4225
Email	b.saunders@imperial.ac.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectives	Does a new colonoscopic viewing technique called narrow band imaging (NBI) help doctors detect more patients with at least one pre-cancerous polyp (adenoma) than conventional colonoscopy using white light alone? The study is to determine if narrow band imaging is better for detecting flat polyps than conventional diagnosis. A high detection rate of flat polyps would indicate that this type of surveillance should be used in the national cancer screening programme.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Surgery: Colonoscopy
Intervention	Narrow band imaging (NBI) versus standard endoscopy.
Intervention type	Procedure/Surgery
Primary outcome measure	Categorical data will be compared with chi-squared test, t-testing on Mann-Whitney U test will be used for continuous data depending on normality
Secondary outcome measures	Not provided at time of registration
Overall study start date	20/01/2006
Completion date	31/12/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	107 patients will be needed for each group, 214 in total. Recruitment completed Summer 2008
Key inclusion criteria	1. Patients over 18 assessed as fit for routine colonoscopy 2. Patients attending for screening or surveillance colonoscopy 3. At least three adenomas or one adenoma >10 mm at previous colonoscopy post colorectal cancer resection screening with positive faecal occult blood tests
Key exclusion criteria	Pre-intubation: 1. Patients with known colitis or polyposis syndromes 2. Unable or unwilling to give consent Pre-caecum to randomisation: 1. Those with poor bowel preparation 2. Unable to reach caecum due to stricture
Date of first enrolment	20/01/2006
Date of final enrolment	31/12/2007

The Wolfson Unit 2nd Floor

Harrow
HA1 3UJ
United Kingdom

Record Provided by the NHSTCT Register - 2006 Update - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Government

North West London Hospitals NHS Trust (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2012		Yes	No