Contact information
Type
Scientific
Primary contact
Mr J Lund
ORCID ID
Contact details
Derby Hospitals NHS Foundation Trust
Department of Surgery
University of Nottingham Medical school at Derby
Derby City General Hospital
Derby
DE22 3DT
United Kingdom
+44 (0)1332 340131 Ext. 5548
jon.lund@nottingham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0077155741
Study information
Scientific title
Early reversal of defunctioning ileostomy
Acronym
Study hypothesis
We hypothesize that early reversal of a defunctioning stoma reduces the cost of stoma care and related complications. We expect the quality of life of those patients who have early reversal will be better that those patients who have a late reversal. We also expect the total time spent in hospital to be reduced.
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 contact details to request a participant information sheet
Condition
Surgery: Ileostomy
Intervention
Participants will be randomly allocated to either the treatment or control group and to one of the subsets by block randomization. Subjects may withdraw their consent at any time and consequently leave the study. Investigator led withdrawal will occur where there is evidence of non-compliance with protocol requirements.
Even if subjects are withdrawn prematurely from the study survival data on such subjects will be collated throughout the protocol defined follow-up period for that subject. Those that fail to attend follow up clinics will be contacted by telephone. The patients normal medications are permitted to continue during the course of the study.
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
Early reversal of defunctioning ileostomy
Secondary outcome measures
Not provided at time of registration
Overall trial start date
31/01/2005
Overall trial end date
31/07/2007
Reason abandoned
Eligibility
Participant inclusion criteria
Patients having defunctioning ileostomy as part of a colorectal procedure, that give informed consent. Patients will be identified through the colorectal meetings, held weekly. Standard treatment will not be affected by involvement in the study. At routine hospital visits the study will be discussed with patients. Those expressing an interest will be given information sheets and contact details.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
Patients that do not give informed consent
Recruitment start date
31/01/2005
Recruitment end date
31/07/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Derby Hospitals NHS Foundation Trust
Derby
DE22 3DT
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 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
Derby Hospitals NHS Foundation Trust (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