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ISRCTN
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ISRCTN75436772
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ClinicalTrials.gov identifier
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Public title
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A placebo controlled trial of medical treatment of submucous fibroids with Gonadotrophin Releasing Hormone (GnRH) analogues prior to hysteroscopic resection
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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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.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised double blind placebo controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Submucous fibroids
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Participants - inclusion criteria
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1. Women with symptomatic submucous fibroids diagnosed on saline infusion hydrosonography
2. Fibroids suitable for hysteroscopic resection
3. Written informed consent obtained
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Participants - exclusion criteria
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1. Fibroids not suitable for hysteroscopic resection
2. Written informed consent declined
3. Malignant histology discovered on histological analysis
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Anticipated start date
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01/10/2005
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Anticipated end date
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01/10/2006
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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120
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Interventions
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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.
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Primary outcome measure(s)
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The success of hysteroscopic resection in achieving complete removal of fibroid.
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Secondary outcome measure(s)
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The length of the operation and associated complications in both treatment and placebo group.
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Sources of funding
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King's College Hospital NHS Trust (UK)
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Trial website
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Publications
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1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20663795
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Contact name
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Mr
Davor
Jurkovic
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Address
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King's College Hospital
Denmark Hill
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City/town
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London
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Zip/Postcode
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SE 5 8RX
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Country
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United Kingdom
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Sponsor
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King's College Hospital (UK)
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Address
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Denmark Hill
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City/town
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London
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Zip/Postcode
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SE5 8RX
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Country
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United Kingdom
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Date applied
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23/08/2005
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Last edited
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15/05/2012
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Date ISRCTN assigned
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30/11/2005
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