Randomised trial of surgery versus fibroid embolisation in the treatment of clinically significant menorrhagia
| ISRCTN | ISRCTN22525542 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22525542 |
| Secondary identifying numbers | N0084120683 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 27/05/2010
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Urological and Genital Diseases
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
Prof Stephen Killick
Scientific
Scientific
The Academic Department of Obstetrics & Gynaecology
Women and Children's
Hull Royal Infirmary
Anlaby Road
Hull
HU3 2JZ
United Kingdom
| S.R.Killick@hull.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Is fibroid embolisation as effective as surgery in the treatment of anaemia due to menorrhagia caused by fibroids? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Urological and Genital Diseases: Menorrhagia |
| Intervention | Please note that as of 27/05/10 the status of this trial was changed to "stopped" as the trial was never started. Randomised controlled study |
| Intervention type | Other |
| Primary outcome measure | 1. End point - one year post treatment or hysterectomy in the embolisation group 2. Outcome measures - Quality of life, haematocrit, length of hospital stay, time to return to work, patient satisfaction, complications, costs |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/06/1999 |
| Completion date | 28/02/2004 |
| Reason abandoned (if study stopped) | Objectives no longer viable |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | One hundred women with clinical anaemia due to menorrhagia caused by fibroids randomised to most appropriate surgery or embolisation. |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/06/1999 |
| Date of final enrolment | 28/02/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
The Academic Department of Obstetrics & Gynaecology
Hull
HU3 2JZ
United Kingdom
HU3 2JZ
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Research organisation
The North and South Bank Research and Development Consortium (UK)
No information available
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 |
