A randomised comparison of microwave endometrial ablation with transcervical resection of the endometrium: follow-up at a minimum of ten years

ISRCTN	ISRCTN45882141
DOI	https://doi.org/10.1186/ISRCTN45882141
Protocol serial number	06/S0801/123
Sponsor	NHS Grampian (UK)
Funder	Aberdeen Royal Infirmary, Gynaecological Endoscopy Research Fund (UK)

Submission date: 06/10/2008
Registration date: 10/12/2008
Last edited: 10/12/2008

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
Aberdeen
AB25 2ZN
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	MEA vsTCRE
Study objectives	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(s)	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)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	01/10/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	263
Key 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
Key exclusion criteria	Unwilling to complete follow-up
Date of first enrolment	11/12/1995
Date of final enrolment	01/10/2008

Locations

Countries of recruitment

United Kingdom
Scotland

Study participating centre

Ward 42

Aberdeen
AB25 2ZN
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	Original trial results	27/11/1999	Yes	No
Results article	Two-year follow-up results	01/06/2002	Yes	No
Results article	Five-year follow-up results	01/04/2005	Yes	No