Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0265109328
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
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
Condition
Surgery: anterior resection and pouch construction
Intervention
We should recruit 40 consenting patients in each group (AR and IPAA) to be randomly assigned to receive a single perioperative dose of topical 0.2% GTN (glycerine trinitrate) ointment or nothing. All patients to be assessed pre- and post-operatively with a clinical incontinence assessment, anorectal manometry and transanal ultrasound.
Intervention type
Drug
Phase
Not Applicable
Drug names
Glycerine trinitrate
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
08/06/2002
Overall trial end date
08/06/2003
Reason abandoned
Eligibility
Participant inclusion criteria
All patients submit to anterior resection (AR) and ileal pouch-anal anastomosis (IPAA)
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
80
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
08/06/2002
Recruitment end date
08/06/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
GI Surgery
Birmingham
B15 2TH
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
University Hospital Birmingham NHS Trust (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
Results - basic reporting
Publication summary