Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Kevin Cooper
ORCID ID
Contact details
Gynaecology Department
Ward 42
Aberdeen Royal Infirmary
Foresterhill
Aberdeen
AB25 2ZN
United Kingdom
+44 (0)1224 554800
Kevin.Cooper@arh.grampian.scot.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
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
Grampian Research Ethics Committee on 24/10/2002 (ref: 02/0232)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/01/2004
Overall trial end date
30/04/2007
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Female
Target number of participants
320
Participant 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
Recruitment start date
01/01/2004
Recruitment end date
30/04/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Gynaecology Department
Aberdeen
AB25 2ZN
United Kingdom
Sponsor information
Organisation
NHS Grampian (UK)
Sponsor details
Research & Development Office
Foresterhill House Annexe
Foresterhill
Aberdeen
AB25 2ZB
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Chief Scientist Office, Scottish Executive Health Department (UK) (ref: CZH/4/117)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19438495
2. 2010 cost utility analysis in http://www.ncbi.nlm.nih.gov/pubmed/20712602
Publication citations
-
Results
Sambrook AM, Cooper KG, Campbell MK, Cook JA, Clinical outcomes from a randomised comparison of Microwave Endometrial Ablation with Thermal Balloon endometrial ablation for the treatment of heavy menstrual bleeding., BJOG, 2009, 116, 8, 1038-1045, doi: 10.1111/j.1471-0528.2009.02181.x.
-
Cost utility analysis
Kilonzo MM, Sambrook AM, Cook JA, Campbell MK, Cooper KG, A cost-utility analysis of microwave endometrial ablation versus thermal balloon endometrial ablation., Value Health, 2010, 13, 5, 528-534, doi: 10.1111/j.1524-4733.2010.00704.x.