A placebo controlled trial of medical treatment of submucous fibroids with Gonadotrophin Releasing Hormone (GnRH) analogues prior to hysteroscopic resection
| ISRCTN | ISRCTN75436772 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75436772 |
| Secondary identifying numbers | N/A |
- Submission date
- 23/08/2005
- Registration date
- 30/11/2005
- Last edited
- 15/05/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Davor Jurkovic
Scientific
Scientific
King's College Hospital
Denmark Hill
London
SE 5 8RX
United Kingdom
Study information
| Study design | Randomised double blind placebo controlled trial |
|---|---|
| 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 | |
| Study objectives | Submucous fibroids are benign tumours of the smooth muscle cells of the uterus. They are found in at least 20 - 25% of women over the age of 35 years although they may be as frequent as 50%. Fibroids are the most common identifiable cause of excessive menstrual blood loss in reproductive age. Hypothesis: To evaluate whether preoperative treatment with GnRH analogues prior to hysteroscopic resection of submucous fibroids increases the success of surgery. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Submucous fibroids |
| Intervention | This randomised double blind placebo controlled trial will include women referred for ultrasound assessment because of a history of excessive menstrual bleeding. Those found on ultrasound examination to have submucous fibroids who fulfil the inclusion criteria will be invited to join the study. Each woman will be randomised to either treatment or placebo group. The treatment group will be 3.6 mg goserelin in a single dose syringe and the placebo group will be 5 ml of 1% lignocaine administered to the same site. All injections will be administered in the anterior abdominal wall every 28 days. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Goserelin |
| Primary outcome measure | The success of hysteroscopic resection in achieving complete removal of fibroid. |
| Secondary outcome measures | The length of the operation and associated complications in both treatment and placebo group. |
| Overall study start date | 01/10/2005 |
| Completion date | 01/10/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 120 |
| Key inclusion criteria | 1. Women with symptomatic submucous fibroids diagnosed on saline infusion hydrosonography 2. Fibroids suitable for hysteroscopic resection 3. Written informed consent obtained |
| Key exclusion criteria | 1. Fibroids not suitable for hysteroscopic resection 2. Written informed consent declined 3. Malignant histology discovered on histological analysis |
| Date of first enrolment | 01/10/2005 |
| Date of final enrolment | 01/10/2006 |
Locations
Countries of recruitment
- United Kingdom
Study participating centre
King's College Hospital
London
SE 5 8RX
United Kingdom
SE 5 8RX
United Kingdom
Sponsor information
King's College Hospital (UK)
Hospital/treatment centre
Hospital/treatment centre
Denmark Hill
London
SE5 8RX
England
United Kingdom
"ROR" |
https://ror.org/01qz4yx77 |
|---|
Funders
Funder type
Hospital/treatment centre
King's College Hospital NHS Trust (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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2010 | Yes | No |
