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ISRCTN
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ISRCTN73816767
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ClinicalTrials.gov identifier
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Public title
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A randomised controlled trial of day-care versus outpatient thermal balloon endometrial ablation using Thermachoice
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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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N0436130477
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Study hypothesis
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The safety and efficacy of thermal balloon endometrial ablation (EA) for the treatment of menorrhagia is well established. However the vast majority have been performed under general anaesthetic with its resultant risk and costs. Thermachoice has been performed in the outpatient setting both in this hospital and several others around the UK. The potential advantages of performing this technique in the outpatient setting are:
- The avoidance of general anaesthesia and its associated risks
- Earlier discharge from hospital
- Faster return to full mobility and fitness
- Less time of work
- Less cost to the patient
We plan to undertake a randomised controlled trial in order to compare out-patient (OP) and day-care (DC) Thermachoice. We will determine the acceptability, recovery and cost of both procedures. Longer term follow up will be undertaken with validated questionnaires comparing patients' menstrual symptoms before and after the treatment. We hypothesise that Thermachoice in the outpatient setting is a safe, acceptable treatment for menorrhagia.
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Lay summary
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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 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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Menorrhagia
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Participants - inclusion criteria
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Patients will be recruited from the outpatient Gynaecology and Hysterscopy clinics.
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Participants - exclusion criteria
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Does not meet inclusion criteria
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Anticipated start date
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01/01/2003
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Anticipated end date
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01/06/2004
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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73 (added 06/10/09)
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Interventions
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Patient will be randomised to
1. Day care group
2. Outpatient group
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Primary outcome measure(s)
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Patient satisfaction and acceptability with the two procedures
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Secondary outcome measure(s)
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To analyse and compare the two procedures in relation to:
1. Speed of recovery
2. Time away from home
3. Time away from work
4. Patient satisfaction at 6 and 12 months
5. Symptomatic changes specially menorrhagia severity and other menstrual symptoms e.g. dysmenorrhea at 6 and 12 months.
6. Cost to the patient, employer and NHS.
7. Health related quality of life changes at 6 and 12 months.
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Sources of funding
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Leeds Teaching Hospitals NHS Trust (UK)
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Trial website
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Publications
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2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17109859
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Contact name
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Dr
F A
Marsh
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Address
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Academic Unit of Obstetrics and Gynaecology
Gledhow Wing
Leeds Teaching Hospitals NHS Trust
Beckett Street
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City/town
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Leeds
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Zip/Postcode
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LS9 7TF
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Country
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United Kingdom
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Tel
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+44 (0)787 946 3287 and 65485
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Fax
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+44 (0)113 242 6496
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Email
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r&d@leedsth.nhs.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
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Address
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The Department of Health,
Richmond House,
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2004
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Last edited
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06/10/2009
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Date ISRCTN assigned
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30/09/2004
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