The effective management of radiation-induced bowel injury: a randomised controlled trial
| ISRCTN | ISRCTN22890916 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22890916 |
| Protocol serial number | N0258191022 |
| Sponsor | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Funder | The Royal Marsden NHS Foundation Trust (UK) |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 29/03/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Contact information
Dr Jervoise Andreyev
Scientific
Scientific
Gastrointestinal Unit, Department of Medicine
Royal Marsden NHS Trust
Fulham Road
London
SW3 6JJ
United Kingdom
| Phone | +44 020 7808 2105 |
|---|---|
| j@andreyev.demon.co.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 | The effective management of radiation-induced bowel injury: a randomised controlled trial |
| Study objectives | To assess which tests can help decide the cause of these patients symptoms' whether treatments in fact improve patients' quality of life and whether these treatments can be delivered usefully by a specialist nurse. |
| Ethics approval(s) | The Royal Marsden Research Ethics Committee (now merged with South West London REC1), 26/03/2007, ref: 07/Q0801/47 |
| Health condition(s) or problem(s) studied | Injury, Occupational Diseases, Poisoning: Radiation |
| Intervention | Randomised test intervention vs standardised intervention, non-blinded (Phase III). Observational (no treatment or diagnostic intervention), Quality of Life Assessment, Qualitative Study |
| Intervention type | Other |
| Primary outcome measure(s) |
Improvement in gastrointestinal symptoms |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/07/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 250 |
| Total final enrolment | 218 |
| Key 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 |
| Key exclusion criteria | Added May 2008: 1. Patient refusing to give informed consent 2. Patients deemed by their clinical oncologist to require immediate gastroenterological assessment |
| Date of first enrolment | 26/11/2007 |
| Date of final enrolment | 12/12/2011 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Royal Marsden NHS Trust
London
SW3 6JJ
United Kingdom
SW3 6JJ
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 | Not provided at time of registration |
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 |
| Plain English results | 23/07/2018 | 29/03/2022 | No | Yes |
Editorial Notes
29/03/2022: The following changes have been made:
1. The Cancer Research UK lay results summary has been added.
2. The total final enrolment number has been added.
22/02/2011: The overall trial end date was changed from 30/06/2010 to 31/07/2012.
