Condition category
Urological and Genital Diseases
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
06/10/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dh.gov.uk/Home/fs/en

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

  1. 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.

Additional files

Editorial Notes