Multicentre randomised controlled trial comparing uterine artery embolisation with surgical treatment for uterine fibroids
| ISRCTN | ISRCTN23023665 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23023665 |
| Secondary identifying numbers | czh/4/1 |
- Submission date
- 08/03/2006
- Registration date
- 16/03/2006
- Last edited
- 04/02/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Uterine fibroids are non-cancerous growths that form on the wall of a woman's womb (uterus). Several different procedures can be used to treat fibroids. Surgical treatments include myomectomy (removal of the fibroids from the wall of the womb) and hysterectomy (removal of the womb). Non-surgical procedures include uterine artery embolisation (UAE), which involves blocking the blood vessels that supply the fibroids, causing them to shrink. The aim of this study is to compare UAE with surgery (hysterectomy and myomectomy) in patients with fibroids who would ordinarily receive surgical treatment.
Who can participate?
Women with symptomatic fibroids who would normally undergo surgery for treatment.
What does the study involve?
Participants are randomly allocated to be treated with either UAE or surgery. Their quality of life is assessed 12 months later.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Gartnavel General Hospital (UK)
When is the study starting and how long is it expected to run for?
November 2000 to September 2010
Who is funding the study?
Chief Scientist Office (UK)
Who is the main contact?
Prof. Jonathan Moss
jon.moss@northglasgow.scot.nhs.uk
Contact information
Scientific
Department of Radiology
Gartnavel General Hospital
1053 Great Western Road
Glasgow
G12 OYN
United Kingdom
| Phone | +44 (0)141 211 3115 |
|---|---|
| jon.moss@northglasgow.scot.nhs.uk |
Study information
| Study design | Open randomised controlled trial allocation 2:1 in favour of new intervention |
|---|---|
| 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 the contact details below to request a patient information sheet |
| Scientific title | Multicentre randomised controlled trial comparing uterine artery embolisation with surgical treatment for uterine fibroids |
| Study acronym | REST |
| Study objectives | Compare results of embolisation with surgery for uterine fibroids. |
| Ethics approval(s) | Multicentre Reseach Ethics Committee (MREC) of Edinburgh, 11/05/2000, ref: MREC/00/0/29 |
| Health condition(s) or problem(s) studied | Uterine fibroids |
| Intervention | Uterine artery embolisation versus surgical treatment |
| Intervention type | Other |
| Primary outcome measure | The 36-item Short Form health survey (SF-36) quality of life questionnaire. |
| Secondary outcome measures | 1. Symptom scores 2. Complications 3. Return to lifestyle events 4. Pain scores 5. Cost analysis |
| Overall study start date | 01/11/2000 |
| Completion date | 01/09/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 200 |
| Key inclusion criteria | Women with symptomatic fibroid who would normally undergo surgery for treatment. |
| Key exclusion criteria | 1. Pregnancy 2. Unable to image with magnetic resonance imaging (MRI) 3. Fibroid size less than 2 cm 4. Subserosal fibroid on a stalk |
| Date of first enrolment | 01/11/2000 |
| Date of final enrolment | 01/09/2010 |
Locations
Countries of recruitment
- United Kingdom
Study participating centre
G12 OYN
United Kingdom
Sponsor information
Hospital/treatment centre
300 Balgray Hill Road
Glasgow
G21 3UR
Scotland
United Kingdom
| Phone | +44 (0)141 211 1817 |
|---|---|
| judith.godden@northglasgow.scot.nhs.uk | |
| Website | http://www.ngt.org |
"ROR" |
https://ror.org/05kdz4d87 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- CSO
- Location
- United Kingdom
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 25/01/2007 | Yes | No | |
| Results article | results | 01/07/2010 | Yes | No | |
| Results article | 5-year results | 01/07/2011 | Yes | No |
Editorial Notes
04/02/2016: Plain English summary added.
