A randomised controlled trial of day-care versus outpatient thermal balloon endometrial ablation using Thermachoice
ISRCTN | ISRCTN73816767 |
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DOI | https://doi.org/10.1186/ISRCTN73816767 |
Secondary identifying numbers | N0436130477 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 06/10/2009
- 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
Dr F A Marsh
Scientific
Scientific
Academic Unit of Obstetrics and Gynaecology
Gledhow Wing
Leeds Teaching Hospitals NHS Trust
Beckett Street
Leeds
LS9 7TF
United Kingdom
Phone | +44 (0)787 946 3287 and 65485 |
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r&d@leedsth.nhs.uk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | |
Study objectives | 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. |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Menorrhagia |
Intervention | Patient will be randomised to 1. Day care group 2. Outpatient group |
Intervention type | Other |
Primary outcome measure | Patient satisfaction and acceptability with the two procedures |
Secondary outcome measures | 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. |
Overall study start date | 01/01/2003 |
Completion date | 01/06/2004 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Female |
Target number of participants | 73 (added 06/10/09) |
Key inclusion criteria | Patients will be recruited from the outpatient Gynaecology and Hysterscopy clinics. |
Key exclusion criteria | Does not meet inclusion criteria |
Date of first enrolment | 01/01/2003 |
Date of final enrolment | 01/06/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Academic Unit of Obstetrics and Gynaecology
Leeds
LS9 7TF
United Kingdom
LS9 7TF
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 |
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Funders
Funder type
Hospital/treatment centre
Leeds Teaching Hospitals NHS Trust (UK)
No information available
Results and Publications
Intention to publish date | |
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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? |
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Results article | results | 01/03/2007 | Yes | No |