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
Completed
- Conditions
- MenorrhagiaUrological and Genital Diseases
- Registration Number
- ISRCTN28184453
- Lead Sponsor
- HS Grampian (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 320
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical outcome using satisfaction levels and menstrual scores (including amenorrhoea rates) after each procedure.
- Secondary Outcome Measures
Name Time Method 1. Operative details and treatment acceptability<br>2. Quality of life<br>3. Health service costs of Microwave Endometrial Ablation to Thermal Balloon Endometrial Ablation