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