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 |
| Secondary identifying numbers | 06/S0801/123 |
- 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
Scientific
Ward 42
Aberdeen Royal Infirmary
Aberdeen
AB25 2ZN
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 11/12/1995 |
| Completion date | 01/10/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 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
- Scotland
- United Kingdom
Study participating centre
Ward 42
Aberdeen
AB25 2ZN
United Kingdom
AB25 2ZN
United Kingdom
Sponsor information
NHS Grampian (UK)
Government
Government
Aberdeen Royal Infirmary
Foresterhill
Aberdeen
AB25 2ZN
United Kingdom
| Website | http://www.nhsgrampian.org |
|---|---|
"ROR" |
https://ror.org/00ma0mg56 |
Funders
Funder type
Hospital/treatment centre
Aberdeen Royal Infirmary, Gynaecological Endoscopy Research Fund (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 | 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 |
