|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ISRCTN |
|
Last refreshed on:
|
19 April 2022 |
|
Main ID: |
ISRCTN22890916 |
|
Date of registration:
|
28/09/2007 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
The effective management of radiation-induced bowel injury: a randomised controlled trial
|
|
Scientific title:
|
The effective management of radiation-induced bowel injury: a randomised controlled trial |
|
Date of first enrolment:
|
26/11/2007 |
|
Target sample size:
|
250 |
|
Recruitment status: |
Completed |
|
URL:
|
https://www.isrctn.com/ISRCTN22890916 |
|
Study type:
|
Interventional |
|
Study design:
|
Randomised controlled trial (Quality of life)
|
|
Phase:
|
Not Applicable
|
|
|
Countries of recruitment
|
|
England
|
United Kingdom
| | | | | | |
|
Contacts
|
|
Name:
|
Jervoise
Andreyev |
|
Address:
|
Gastrointestinal Unit, Department of Medicine
Royal Marsden NHS Trust
Fulham Road
SW3 6JJ
London
United Kingdom |
|
Telephone:
|
+44 020 7808 2105 |
|
Email:
|
j@andreyev.demon.co.uk |
|
Affiliation:
|
|
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: Patients who have a life expectancy of more than 1 year and who have received radical pelvic radiotherapy with curative intent six months previously and who subsequently have developed new onset troublesome gastrointestinal symptoms
Exclusion criteria:
Added May 2008:
1. Patient refusing to give informed consent
2. Patients deemed by their clinical oncologist to require immediate gastroenterological assessment
Age minimum:
Age maximum:
Gender:
Not Specified
|
|
Health Condition(s) or Problem(s) studied
|
Injury, Occupational Diseases, Poisoning: Radiation
Injury, Occupational Diseases, Poisoning
Radiation
|
|
Intervention(s)
|
Randomised test intervention vs standardised intervention, non-blinded (Phase III).
Observational (no treatment or diagnostic intervention), Quality of Life Assessment, Qualitative Study
|
|
Primary Outcome(s)
|
|
Improvement in gastrointestinal symptoms
|
|
Secondary Outcome(s)
|
|
Not provided at time of registration
|
|
Secondary ID(s)
|
|
N0258191022
|
|
Source(s) of Monetary Support
|
|
The Royal Marsden NHS Foundation Trust (UK)
|
|
Ethics review
|
Status:
Approval date:
Contact:
The Royal Marsden Research Ethics Committee (now merged with South West London REC1), 26/03/2007, ref: 07/Q0801/47
|
|
Results
|
|
Results available:
|
Yes |
|
Date Posted:
|
|
|
Date Completed:
|
31/07/2012 |
|
URL:
|
|
|
|