Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0265041723
Study information
Scientific title
Acronym
Study hypothesis
Whether a wider stapled anastomosis is associated with a lower recurrence rate than a sutured end to end anastomosis.
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
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Digestive System: Crohn's disease
Intervention
Prospective randomized trial to compare stapled "functional end to end anastomosis" (side to side in reality) with sutured end to end anastomosis in patients having:
a. Resection of ileocaecal Crohn's disease
b. Resection of recurrent ileocaecal Crohn's disease.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Lower recurrence rate.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2000
Overall trial end date
01/01/2008
Reason abandoned
Eligibility
Participant inclusion criteria
Patients with ileocolonic Crohn's disease needing a resection.
Participant type
Patient
Age group
Not Specified
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
01/01/2000
Recruitment end date
01/01/2008
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
1. 1999 results in http://www.ncbi.nlm.nih.gov/pubmed/10466883
Publication citations
-
Results
Yamamoto T, Bain IM, Mylonakis E, Allan RN, Keighley MR, Stapled functional end-to-end anastomosis versus sutured end-to-end anastomosis after ileocolonic resection in Crohn disease., Scand. J. Gastroenterol., 1999, 34, 7, 708-713.