Microwave endometrial ablation versus thermal balloon endometrial ablation - a pragmatic randomised comparison of postmenstrual treatment under general or local anaesthesia: clinical outcomes, patient acceptability and cost
| ISRCTN | ISRCTN28184453 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28184453 |
| Secondary identifying numbers | N/A |
- Submission date
- 20/12/2006
- Registration date
- 21/02/2007
- Last edited
- 03/05/2011
- 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
Gynaecology Department
Ward 42
Aberdeen Royal Infirmary
Foresterhill
Aberdeen
AB25 2ZN
United Kingdom
| Phone | +44 (0)1224 554800 |
|---|---|
| Kevin.Cooper@arh.grampian.scot.nhs.uk |
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 objectives | The aim of the study is to compare Microwave Endometrial Ablation (MEA) with Thermal Balloon Endometrial Ablation (TBEA) under general or local anaesthesia in the postmenstrual phase in an adequately powered prospective randomised trial. |
| Ethics approval(s) | Grampian Research Ethics Committee on 24/10/2002 (ref: 02/0232) |
| Health condition(s) or problem(s) studied | Menorrhagia |
| Intervention | Endometrial ablation (MEA) with thermal balloon endometrial ablation (TBEA). Microwave Endometrial Ablation MEA uses microwave energy, which emanates from the probe tip to effectively paint the inside of the uterus with microwave energy. The MEA causes endometrial destruction to a predictable depth through a tissue heating effect. The procedure itself lasts two to three minutes on average and utilises an 8.5 mm probe. Thermal Balloon Endometrial Ablation TBEA (Thermachoice, Gynecare Inc) uses a balloon that is filled with a 5% Dextrose solution that is heated to provide the Endometrial effect. It uses a 5mm catheter, which requires to be introduced into the uterus prior to inflation. The balloon probe is significantly smaller than the MEA probe and may offer advantages through reduced need for cervical dilation. Unlike the microwave technique, apart from siting the device and ensuring that normal operating pressures are achieved, there is no operator input required for the balloon treatment phase, which lasts eight minutes. A clinical research fellow of specialist registrar level performed all procedures in theatre. All procedures were performed under general or local anaesthesia plus or minus sedation in day case theatre. |
| Intervention type | Other |
| Primary outcome measure | Clinical outcome using satisfaction levels and menstrual scores (including amenorrhoea rates) after each procedure. |
| Secondary outcome measures | 1. Operative details and treatment acceptability 2. Quality of life 3. Health service costs of Microwave Endometrial Ablation to Thermal Balloon Endometrial Ablation |
| Overall study start date | 01/01/2004 |
| Completion date | 30/04/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Target number of participants | 320 |
| Key inclusion criteria | Women in the catchment area of Aberdeen Royal Infirmary with dysfunctional uterine bleeding who: 1. Have completed their family 2. Have normal endometrial pathology 3. Have a regular uterus cavity 4. Are willing to be randomised to microwave endometrial ablation or thermal balloon endometrial ablation under local anaesthesia |
| Key exclusion criteria | 1. Unable or unwilling to give informed consent 2. Those who in the opinion of the attending physician are thought to have limited life expectancy (less than one year) 3. Patients who currently or have within the last three months been involved with another research project |
| Date of first enrolment | 01/01/2004 |
| Date of final enrolment | 30/04/2007 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Gynaecology Department
Aberdeen
AB25 2ZN
United Kingdom
AB25 2ZN
United Kingdom
Sponsor information
NHS Grampian (UK)
Government
Government
Research & Development Office
Foresterhill House Annexe
Foresterhill
Aberdeen
AB25 2ZB
United Kingdom
| Website | http://www.nhsgrampian.org |
|---|---|
"ROR" |
https://ror.org/00ma0mg56 |
Funders
Funder type
Government
Chief Scientist Office, Scottish Executive Health Department (UK) (ref: CZH/4/117)
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 | results | 01/07/2009 | Yes | No | |
| Other publications | cost utility analysis | 01/08/2010 | Yes | No |
