Condition category
Urological and Genital Diseases
Date applied
18/11/2009
Date assigned
25/11/2009
Last edited
13/02/2013
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 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

http://www.nhsgrampian.org/

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

  1. 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.

  2. 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.

Additional files

Editorial Notes