Contact information
Type
Scientific
Primary contact
Dr F A Marsh
ORCID ID
Contact details
Academic Unit of Obstetrics and Gynaecology
Gledhow Wing
Leeds Teaching Hospitals NHS Trust
Beckett Street
Leeds
LS9 7TF
United Kingdom
+44 (0)787 946 3287 and 65485
r&d@leedsth.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0436130477
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Menorrhagia
Intervention
Patient will be randomised to
1. Day care group
2. Outpatient group
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/01/2003
Overall trial end date
01/06/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Patients will be recruited from the outpatient Gynaecology and Hysterscopy clinics.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
73 (added 06/10/09)
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/01/2003
Recruitment end date
01/06/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Academic Unit of Obstetrics and Gynaecology
Leeds
LS9 7TF
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Leeds Teaching Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17109859
Publication citations
-
Results
Marsh F, Thewlis J, Duffy S, Randomized controlled trial comparing Thermachoice III* in the outpatient versus daycase setting., Fertil. Steril., 2007, 87, 3, 642-650, doi: 10.1016/j.fertnstert.2006.07.1502.