A placebo controlled trial of medical treatment of submucous fibroids with gonadotropin releasing hormone (GnRH) analogues prior to hysteroscopic resection.
ISRCTN | ISRCTN06560767 |
---|---|
DOI | https://doi.org/10.1186/ISRCTN06560767 |
Secondary identifying numbers | N0116148335 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 18/08/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr D Jurkovic
Scientific
Scientific
Department of Obstetrics and Gynaecology
King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom
Study information
Study design | Double blind randomised placebo controlled trial |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | |
Study objectives | To evaluate whether pre-operative treatment with gonadotropin releasing hormone (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 | Surgery: Gynaecological |
Intervention | Women undergoing TCRM will be randomised to receive pre-operative treatment with gonadotropin releasing hormone (GnRH) or placebo. The duration of follow up was 6 weeks, post operatively |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | gonadotropin releasing hormone (GnRH) |
Primary outcome measure | Added 18/08/10: Completeness of fibroid resection |
Secondary outcome measures | Added 18/08/10: 1. Duration of the TCRM 2. Fluid deficit recorded at TCRM 3. Resolution of symptoms post-operatively 4. Number of subsequent fibroid related operations |
Overall study start date | 01/02/2003 |
Completion date | 01/12/2006 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Adult |
Lower age limit | 18 Years |
Sex | Female |
Target number of participants | 47 (added 18/08/10; see publication) |
Key inclusion criteria | Added 18/08/10: 1. Women found to have submucous fibroids on three-dimensional saline infusion sonohysterography (3D SIS) 2. Removal of fibroids by hysteroscopic transcervical resection of myoma (TCRM) |
Key exclusion criteria | Does not match inclusion criteria |
Date of first enrolment | 01/02/2003 |
Date of final enrolment | 01/12/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Obstetrics and Gynaecology
London
SE5 9RS
United Kingdom
SE5 9RS
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
---|---|
dhmail@doh.gsi.org.uk | |
Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Hospital/treatment centre
Kings College Hospital NHS Trust R&D Consortium (UK) - NHS R&D support funding
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 |