Condition category
Urological and Genital Diseases
Date applied
20/12/2006
Date assigned
21/02/2007
Last edited
03/05/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.abdn.ac.uk/hsru/hta/endometrial.shtml

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

http://www.nhsgrampian.org

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

  1. 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.

  2. 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.

Additional files

Editorial Notes