Contact information
Type
Scientific
Primary contact
Dr Kevin Cooper
ORCID ID
Contact details
Ward 42
Aberdeen Royal Infirmary
Foresterhill
Aberdeen
AB25 2ZN
United Kingdom
kevin.cooper@nhs.net
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CSO - CZH/4/21
Study information
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
Acronym
Study hypothesis
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
Grampian Research Ethics Committee approved on the 3rd August 2000 (ref: 00/0023)
Study design
Single centre unblinded randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/04/2001
Overall trial end date
31/03/2003
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
210
Participant exclusion criteria
1. Unsuitable for endometrial ablation
2. Unwilling to have procedure under local anaesthetic
3. Allergic to local anaesthetic agents
Recruitment start date
01/04/2001
Recruitment end date
31/03/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Ward 42, Aberdeen Royal Infirmary
Aberdeen
AB25 2ZN
United Kingdom
Sponsor information
Organisation
NHS Grampian (UK)
Sponsor details
Asgrove House
Foresterhill Site
Aberdeen
AB25 2ZN
United Kingdom
susan.ingram@nhs.net
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Chief Scientist Office of the Scottish Executive Health Department (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
1. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16045526
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20374582
Publication citations
-
Results
Jack SA, Cooper KG, Seymour J, Graham W, Fitzmaurice A, Perez J, A randomised controlled trial of microwave endometrial ablation without endometrial preparation in the outpatient setting: patient acceptability, treatment outcome and costs., BJOG, 2005, 112, 8, 1109-1116, doi: 10.1111/j.1471-0528.2005.00630.x.
-
Results
Sambrook AM, Jack SA, Cooper KG, Outpatient microwave endometrial ablation: 5-year follow-up of a randomised controlled trial without endometrial preparation versus standard day surgery with endometrial preparation., BJOG, 2010, 117, 4, 493-496, doi: 10.1111/j.1471-0528.2009.02476.x.