Microwave endometrial ablation without endometrial preparation in the outpatient setting

ISRCTN	ISRCTN95516133
DOI	https://doi.org/10.1186/ISRCTN95516133
Secondary identifying numbers	CSO - CZH/4/21

Submission date: 18/11/2009
Registration date: 25/11/2009
Last edited: 13/02/2013

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 Kevin Cooper
Scientific

Ward 42, Aberdeen Royal Infirmary
Foresterhill
Aberdeen
AB25 2ZN
United Kingdom

Email	kevin.cooper@nhs.net

Study information

Study design	Single centre unblinded randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	The effects of hormonal endometrial preparation before microwave endometrial ablation: patient acceptability, treatment outcomes and costs - a single centre unblinded randomised controlled trial
Study objectives	Is microwave ablation outcome affected by undertaking without endometrial preparation and in an outpatient setting? A randomised trial comparing it to traditional preparation and treatment in operating theatre.
Ethics approval(s)	Grampian Research Ethics Committee approved on the 3rd August 2000 (ref: 00/0023)
Health condition(s) or problem(s) studied	Menorrhagia
Intervention	Trial arm one: microwave endometrial ablation (MEA) 4 weeks after endometrial preparation with danazol or GnRH analogue in theatre setting Trial arm two: MEA out-patient setting 5 to 7 days after start of period All under local anaesthetic. There is a baseline assessment of menstrual dysfunction and quality of life. Operative outcomes, discomfort, analgesic requirements and acceptability are all measured. Follow up at one year and five years to determine satisfaction with treatment, quality of life (SF-36), menstrual outcomes and costs. All by postal questionnaires.
Intervention type	Other
Primary outcome measure	Patient acceptability
Secondary outcome measures	Measured immediately-post procedure and at 1 year and 5 years: 1. Menstrual outcomes 2. Quality of life 3. Costs
Overall study start date	01/04/2001
Completion date	31/03/2003

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	210
Key inclusion criteria	1. Women aged 30 to 55 years 2. Suitable for endometrial ablation as treatment for heavy periods 3. Premenopausal 4. Not planning to have any (further) children
Key exclusion criteria	1. Unsuitable for endometrial ablation 2. Unwilling to have procedure under local anaesthetic 3. Allergic to local anaesthetic agents
Date of first enrolment	01/04/2001
Date of final enrolment	31/03/2003

Locations

Countries of recruitment

Scotland
United Kingdom

Study participating centre

Ward 42, Aberdeen Royal Infirmary

Aberdeen
AB25 2ZN
United Kingdom

Sponsor information

NHS Grampian (UK)
Government

Asgrove House
Foresterhill Site
Aberdeen
AB25 2ZN
United Kingdom

Email	susan.ingram@nhs.net
Website	http://www.nhsgrampian.org/
"ROR"	https://ror.org/00ma0mg56

Funders

Funder type

Government

Chief Scientist Office of the Scottish Executive Health Department (UK)

No information available

Results and Publications

Intention to publish date
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?
Results article	results	01/08/2005		Yes	No
Results article	results	01/03/2010		Yes	No