Condition category
Urological and Genital Diseases
Date applied
06/10/2008
Date assigned
10/12/2008
Last edited
10/12/2008
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
Aberdeen
AB25 2ZN
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

06/S0801/123

Study information

Scientific title

Acronym

MEA vsTCRE

Study hypothesis

To compare outcomes and further operations at a minimum of ten years following microwave endometrial ablation (MEA™) or transcervical resection of the endometrium (TCRE).

Ethics approval

Original study: Grampian Health Board Joint Ethical Committee, approved on 11/12/1995 (Project no.: 2459)
Follow-up study: Grampian Local Research Ethics Committee, approved on 05/02/2007 (ref: 06/S0801/123)

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

Heavy menstrual bleeding

Intervention

Interventions:
Microwave endometrial ablation (MEA™) vs transcervical resection of the endometrium (TCRE).

Start date of RCT: 11/12/1995
End date of RCT: 01/12/1998 (end of follow-up)

Follow-up study: postal questionnaires and operative databank review.

Start date of the follow-up study: 01/03/2007
End date of the follow-up study: 01/10/2008

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Patient satisfaction and acceptability of treatment, assessed by questionnaires (Timepoints: T1-T5).

Timepoints:
T0: Within 6 weeks after operation
T1: 4 months after operation
T2: 12 months after operation
T3: Minimum of 2 years after operation
T4: Minimum of 5 years after operation
T5: Minimum of 10 years after operation

Additional data were also obtained via a hospital database.

Secondary outcome measures

The following were assessed at timepoints T0-T5:
1. Menstrual symptoms (questionnaires)
2. Changes in health related quality of life, assessed by the SF-36 Health Survey
3. Additional treatments received (questionnaires)

Timepoints:
T0: Within 6 weeks after operation
T1: 4 months after operation
T2: 12 months after operation
T3: Minimum of 2 years after operation
T4: Minimum of 5 years after operation
T5: Minimum of 10 years after operation

Additional data were also obtained via a hospital database.

Overall trial start date

11/12/1995

Overall trial end date

01/10/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Premenopausal women, no age limits
2. Heavy menstrual loss
3. Family was complete (i.e. no desire for further children)
4. No endometrial atypia
5. Uterine size not greater than ten weeks size

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

263

Participant exclusion criteria

Unwilling to complete follow-up

Recruitment start date

11/12/1995

Recruitment end date

01/10/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Ward 42
Aberdeen
AB25 2ZN
United Kingdom

Sponsor information

Organisation

NHS Grampian (UK)

Sponsor details

Aberdeen Royal Infirmary
Foresterhill
Aberdeen
AB25 2ZN
United Kingdom

Sponsor type

Government

Website

http://www.nhsgrampian.org

Funders

Funder type

Hospital/treatment centre

Funder name

Aberdeen Royal Infirmary, Gynaecological Endoscopy Research Fund (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

1999 Original trial results in http://www.ncbi.nlm.nih.gov/pubmed/10584722
2002 Two-year follow-up results in http://www.ncbi.nlm.nih.gov/pubmed/12052586
2005 Five-year follow-up results in http://www.ncbi.nlm.nih.gov/pubmed/15777447

Publication citations

  1. Cooper KG, Bain C, Parkin DE, Comparison of microwave endometrial ablation and transcervical resection of the endometrium for treatment of heavy menstrual loss: a randomised trial., Lancet, 1999, 354, 9193, 1859-1863, doi: 10.1016/S0140-6736(99)04101-X.

  2. Bain C, Cooper KG, Parkin DE, Microwave endometrial ablation versus endometrial resection: a randomized controlled trial., Obstet Gynecol, 2002, 99, 6, 983-987.

  3. Cooper KG, Bain C, Lawrie L, Parkin DE, A randomised comparison of microwave endometrial ablation with transcervical resection of the endometrium; follow up at a minimum of five years., BJOG, 2005, 112, 4, 470-475, doi: 10.1111/j.1471-0528.2004.00511.x.

Additional files

Editorial Notes