A randomised controlled trial of day-care versus outpatient thermal balloon endometrial ablation using Thermachoice

ISRCTN	ISRCTN73816767
DOI	https://doi.org/10.1186/ISRCTN73816767
Protocol serial number	N0436130477
Sponsor	Department of Health
Funder	Leeds Teaching Hospitals NHS Trust (UK)

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

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
Email	r&d@leedsth.nhs.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	Patient satisfaction and acceptability with the two procedures
Key secondary outcome measure(s)	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.
Completion date	01/06/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	73
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

United Kingdom
England

Study participating centre

Academic Unit of Obstetrics and Gynaecology

Leeds
LS9 7TF
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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	01/03/2007		Yes	No