Early reversal of defunctioning ileostomy
| ISRCTN | ISRCTN85414968 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85414968 |
| Protocol serial number | N0077155741 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Funder | Derby Hospitals NHS Foundation Trust (UK) NHS R&D Support Funding |
- 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
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 |
|---|---|
| jon.lund@nottingham.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | 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 Even if subjects are withdrawn prematurely from the study survival data on such subjects will be collated throughout the protocol defined follow-up period for that subject.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(s) |
Early reversal of defunctioning ileostomy |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/07/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Derby Hospitals NHS Foundation Trust
Derby
DE22 3DT
United Kingdom
DE22 3DT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
19/09/2016: No publications found, verifying study status with principal investigator.
