Condition category
Cancer
Date applied
08/03/2006
Date assigned
16/03/2006
Last edited
04/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jonathan Moss

ORCID ID

Contact details

Department of Radiology
Gartnavel General Hospital
1053 Great Western Road
Glasgow
G12 OYN
United Kingdom
+44 (0)141 211 3115
jon.moss@northglasgow.scot.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

czh/4/1

Study information

Scientific title

Multicentre randomised controlled trial comparing uterine artery embolisation with surgical treatment for uterine fibroids

Acronym

REST

Study hypothesis

Compare results of embolisation with surgery for uterine fibroids.

Ethics approval

Multicentre Reseach Ethics Committee (MREC) of Edinburgh, 11/05/2000, ref: MREC/00/0/29

Study design

Open randomised controlled trial allocation 2:1 in favour of new intervention

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 the contact details below to request a patient information sheet

Condition

Uterine fibroids

Intervention

Uterine artery embolisation versus surgical treatment

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/11/2000

Overall trial end date

01/09/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Women with symptomatic fibroid who would normally undergo surgery for treatment.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

200

Participant 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

Recruitment start date

01/11/2000

Recruitment end date

01/09/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Gartnavel General Hospital
Glasgow
G12 OYN
United Kingdom

Sponsor information

Organisation

Greater Glasgow Health Board (North Glasgow University Hospitals Division) (UK)

Sponsor details

300 Balgray Hill Road
Glasgow
G21 3UR
United Kingdom
+44 (0)141 211 1817
judith.godden@northglasgow.scot.nhs.uk

Sponsor type

Government

Website

http://www.ngt.org

Funders

Funder type

Government

Funder name

Chief Scientist Office (UK) (ref: CZH/4/1)

Alternative name(s)

CSO

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

United Kingdom

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

2007 results in: http://www.ncbi.nlm.nih.gov/pubmed/17251532
2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20465558
2011 5-year results in: http://www.ncbi.nlm.nih.gov/pubmed/21481151

Publication citations

  1. Results

    Edwards RD, Moss JG, Lumsden MA, Wu O, Murray LS, Twaddle S, Murray GD, , Uterine-artery embolization versus surgery for symptomatic uterine fibroids., N. Engl. J. Med., 2007, 356, 4, 360-370, doi: 10.1056/NEJMoa062003.

  2. Results

    Rashid S, Khaund A, Murray LS, Moss JG, Cooper K, Lyons D, Murray GD, Lumsden MA, The effects of uterine artery embolisation and surgical treatment on ovarian function in women with uterine fibroids., BJOG, 2010, 117, 8, 985-989, doi: 10.1111/j.1471-0528.2010.02579.x.

  3. Moss JG, Cooper KG, Khaund A, Murray LS, Murray GD, Wu O, Craig LE, Lumsden MA, Randomised comparison of uterine artery embolisation (UAE) with surgical treatment in patients with symptomatic uterine fibroids (REST trial): 5-year results., BJOG, 2011, 118, 8, 936-944, doi: 10.1111/j.1471-0528.2011.02952.x.

Additional files

Editorial Notes

04/02/2016: Plain English summary added.