Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0249132150
Study information
Scientific title
Randomised controlled trial of complete bowel preparation vs distal bowel cleansing in the management of patients referred under fast track guidelines for colorectal cancer
Acronym
Study hypothesis
Whis is preferable in the management of patients undergoing flexible sigmoidoscopy - complete bowel preparation or distal bowel cleansing?
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
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Cancer: Colorectal
Intervention
1. Complete bowel preparation
2. Distal bowel cleansing
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
1. Patient satisfaction
2. Bowel preparation efficacy
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/11/2003
Overall trial end date
01/06/2006
Reason abandoned
Eligibility
Participant inclusion criteria
200 patients undergoing flexible sigmoidoscopy following fast track referral
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
200
Participant exclusion criteria
Inability to self-administer enema, diabetes mellitus (unless solely diet controlled)
Recruitment start date
01/11/2003
Recruitment end date
01/06/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Taunton & Somerset Hospital
Taunton
TA1 5DA
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
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
Taunton and Somerset Research and Development Consortium (UK) NHS R&D Support Funding
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
Results - basic reporting
Publication summary