Condition category
Surgery
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
19/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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Even if subjects are withdrawn prematurely from the study survival data on such subjects will be collated throughout the protocol defined follow-up period for that subject.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 patient’s 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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes

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