Condition category
Urological and Genital Diseases
Date applied
14/06/2010
Date assigned
29/07/2010
Last edited
04/07/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Kevin Cooper

ORCID ID

Contact details

Ward 42
Aberdeen Royal Infirmary
Foresterhill
Aberdeen
AB25 2ZN
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Patient satisfaction, menstrual outcome and costs following blind versus visual second-generation ablation for the treatment of menorrhagia: a randomised controlled trial

Acronym

Study hypothesis

Current study hypothesis as of 13/10/2011:
The aim of the study is to compare visual endometrial ablation (Hydrotheramablator) with blind endometrial ablation (Thermal balloon or Novasure Bipolar array) under general or local anaesthesia in the postmenstrual phase in an adequately powered, double-blind, prospective randomised controlled trial. Pre-operative data, 1-year and 5-year data will be taken.

Previous study hypothesis:
The aim of the study is to compare Hydro ThermAblator (HTA) with Microwave Endometrial Ablation (MEA) under general or local anaesthesia in the postmenstrual phase in an adequately powered, double-blind, prospective randomised controlled trial. Pre-operative data, 1-year and 5-year data will be taken.

Ethics approval

NHS Grampian Ethics Committee –- approval pending

Study design

Double-blind randomised active-controlled parallel-group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

Women's health - reproductive disease

Intervention

Patients will be randomised in a 1:1 basis to either blind or visual endometrial ablation performed under local or general anaesthesia in the immediate post-menstrual phase. Patients can choose their anaesthetic and will have their lining prepared by a medically induced withdrawal bleed. HTA , Thermachoice and Novasure are all NICE-approved methods of endometrial ablation and will be used within their CE mark. The duration of follow-up will be 1 year in the short term, with a follow up at 5 and 10 years to assess long-term outcomes.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Patient satisfaction with each technique, measured using a six-point Likert scale post-operatively and at 6 and 12 months.

Secondary outcome measures

1. Comparison of operative details, e.g.
1.1. Times
1.2. Difficulties
1.3. Numbers needing general anaesthetic
1.4. Acceptability of treatment measured using a six-point Likert scale post-operatively and at 6 and 12 months
1.5. Operative pain assessed by Visual Analogue Scale (VAS) and McGill Pain Questionnaire
2. Menstrual outcome
2.1. Menstrual Bleeding and Pain Scores assessed with standardised local bleeding/pain scores (0-50) and follow-up Pictorial Bleeding Assessment Chart (PBLAC) scores, at baseline, 6 and 12 months
2.2. Number of women having no periods after each procedure
3. Quality of life, measured by SF-12
4. Health service costs of Microwave Endometrial Ablation to Hydro ThermAblator ablation under general or local anaesthesia performed in the post-menstrual phase
5. Complication rates
Follow up at 5 and 10 years will assess long-term outcomes.

Overall trial start date

10/01/2012

Overall trial end date

10/01/2017

Reason abandoned

Lack of funding/sponsorship

Eligibility

Participant inclusion criteria

1. Patients eligible for endometrial ablation and be willing to be randomised to either treatment
2. Normal endometrial biopsy results
3. Uterine cavity less than 12 cm
4. Completed their family, use reliable contraception and otherwise be acceptant of hysterectomy
5. A pre-operative ultrasound scan must confirm they are suitable for either MEA or HTA
6. Pre-operative data, 1-year and 5-year data will be taken

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

220

Participant exclusion criteria

1. Desire for further family
2. Abnormal endometrial pathology
3. Uterine cavity > 12 cm
4. Normal or light periods
5. Previous classical caesarean section/myomectomy/hysterotomy
6. Previous caesarean section scar less than 10 mm
7. Acute uterine infection

Recruitment start date

10/01/2012

Recruitment end date

10/01/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Aberdeen Royal Infirmary
Aberdeen
AB25 2ZN
United Kingdom

Sponsor information

Organisation

NHS Grampian Endowments (UK)

Sponsor details

NHS Grampian Endowments
Research & Development Department
Foresterhill House Annexe
Foresterhill
Aberdeen
AB25 2ZB
United Kingdom
+44 (0)131 244 2246
abc@email.com

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

NHS Endowments. An application for Health Technologies Agency (HTA) funding is in progress

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

Publication citations

Additional files

Editorial Notes

04/07/2016: This trial did not take place due to lack of funding. 13/10/2011: amendments were made to the trial record due to MEA being discontinued as a technology after being bought out by Hologic: 1. The public and scientific titles were updated. The original titles were 'Hydrothermablator Endometrial Ablation versus Microwave Endometrial Ablation Trial: A trial comparing two methods of treating heavy periods to each other' and 'Hydrothermablator Endometrial Ablation versus Microwave Endometrial Ablation Trial: A randomised comparison of treatment in the postmenstrual phase, clinical outcomes, patient acceptability +/- and costs', respectively. 2. The target number of participants field was updated. The original target number of participants was 200. 3. The overall trial start and end dates were updated. The original dates were 01/08/2010 and 01/08/2012, respectively. 4. The sources of funding field was updated. The original text was 'Chief Scientist Office (CSO) (UK) - Scottish Health Executive' (application for research grant in progress)'.