Microwave endometrial ablation without endometrial preparation in the outpatient setting
| ISRCTN | ISRCTN95516133 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95516133 |
| Protocol serial number | CSO - CZH/4/21 |
| Sponsor | NHS Grampian (UK) |
| Funder | Chief Scientist Office of the Scottish Executive Health Department (UK) |
- Submission date
- 18/11/2009
- Registration date
- 25/11/2009
- Last edited
- 13/02/2013
- 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
Foresterhill
Aberdeen
AB25 2ZN
United Kingdom
| kevin.cooper@nhs.net |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single centre unblinded randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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 |
| Study objectives | 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(s) | Grampian Research Ethics Committee approved on the 3rd August 2000 (ref: 00/0023) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) | Patient acceptability |
| Key secondary outcome measure(s) | Measured immediately-post procedure and at 1 year and 5 years: 1. Menstrual outcomes 2. Quality of life 3. Costs |
| Completion date | 31/03/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 210 |
| Key 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 |
| Key exclusion criteria | 1. Unsuitable for endometrial ablation 2. Unwilling to have procedure under local anaesthetic 3. Allergic to local anaesthetic agents |
| Date of first enrolment | 01/04/2001 |
| Date of final enrolment | 31/03/2003 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
Study participating centre
Ward 42, Aberdeen Royal Infirmary
Aberdeen
AB25 2ZN
United Kingdom
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 | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2005 | Yes | No | |
| Results article | results | 01/03/2010 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
