Early reversal of defunctioning ileostomy

ISRCTN	ISRCTN85414968
DOI	https://doi.org/10.1186/ISRCTN85414968
Secondary identifying numbers	N0077155741

Submission date: 29/09/2006
Registration date: 29/09/2006
Last edited: 19/09/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr J Lund
Scientific

Derby Hospitals NHS Foundation Trust
Department of Surgery
University of Nottingham Medical school at Derby
Derby City General Hospital
Derby
DE22 3DT
United Kingdom

Phone	+44 (0)1332 340131 Ext. 5548
Email	jon.lund@nottingham.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Early reversal of defunctioning ileostomy
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 Even if subjects are withdrawn prematurely from the study survival data on such subjects will be collated throughout the protocol defined follow-up period for that subject.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
Primary outcome measure	Early reversal of defunctioning ileostomy
Secondary outcome measures	Not provided at time of registration
Overall study start date	31/01/2005
Completion date	31/07/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	60
Key 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.
Key exclusion criteria	Patients that do not give informed consent
Date of first enrolment	31/01/2005
Date of final enrolment	31/07/2007

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Derby Hospitals NHS Foundation Trust

Derby
DE22 3DT
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Derby Hospitals NHS Foundation Trust (UK) NHS R&D Support Funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

19/09/2016: No publications found, verifying study status with principal investigator.