Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0436183019
Study information
Scientific title
An analysis of the performance of CT colonoscopy versus optical colonoscopy evaluation of the colon in symptomatic patients in SJUH
Acronym
Study hypothesis
We aim to analyse the performance of CT colonoscopy performed prior to optical colonoscopy in symptomatic patients over 60 attending for colonoscopy. In a recent consensus statement by the European Society of Abdominal and Gastrointestinal Radiologists all experts had endoscopic correlation for 50 cases and most for over 200. As this is a new technique we aim to formally compare our performance with published sensitivity and specificity data in the literature for quality control.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Condition
Surgery: Colonoscopy
Intervention
CT colonoscopy versus optical colonoscopy evaluation
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measure
CT colonoscopy findings will be compared with the planned optical examination which follows. Segmental unblinding of the colonoscopist to the CT results for each colonic segment (on withdrawal of the endoscope) will allow comparison of the sensitivity of CT and optical colonoscopy to detect polyps.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/05/2006
Overall trial end date
01/11/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All patients aged over 60 attending St James's Hospital endoscopy department for optical colonoscopy during the study period will be eligible for enrolment allowing for the exclusion criteria detailed in the proposal.
Participant type
Patient
Age group
Senior
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/05/2006
Recruitment end date
01/11/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Radiology
Leeds
LS9 7TF
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Leeds Teaching Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list