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ISRCTN
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ISRCTN43442156
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ClinicalTrials.gov identifier
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Public title
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Blind versus visual endometrial ablation: A randomised controlled trial
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Scientific title
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Patient satisfaction, menstrual outcome and costs following blind versus visual second generation ablation for the treatment of menorrhagia: A randomised controlled trial
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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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.
Please note that as of 13/10/2011 amendments have been made to the trial record due to MEA being discontinued as a technology after being bought out by Hologic.
Both public and scientific titles have been 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.
Both start and end dates have been updated. The original dates were 01/08/2010 and 01/08/2012 respectively.
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Lay summary
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Not provided at time of registration
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Ethics approval
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IRAS Trial Application in progress. Local ethics committee is NHS Grampian Ethics Committee.
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Study design
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Double blind randomised active controlled parallel group trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Women's Health - Reproductive Disease.
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Participants - inclusion criteria
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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 12cm
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
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Participants - exclusion criteria
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1. Desire for further family
2. Abnormal endometrial pathology
3. Uterine Cavity > 12cm
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
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Anticipated start date
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10/01/2012
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Anticipated end date
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10/01/2017
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use contact details below to request a patient information sheet
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Target number of participants
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Added 13/10/2011: 220 (200 at time of registration)
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Interventions
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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.
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Primary outcome measure(s)
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Patient satisfaction with each technique. Measured using a six point Linkert scale, post-operatively and at 6 and 12 months.
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Secondary outcome measure(s)
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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 6 point Linkert 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.
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Sources of funding
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Current sources of funding as of 13/10/2011:
NHS Endowments.
An application for Health Technologies Agency ( HTA ) funding is in progress.
Previous sources of funding:
Chief Scientist Office (CSO) (UK) - Scottish Health Executive (application for research grant in progress)
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Trial website
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Publications
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Contact name
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Dr
Kevin
Cooper
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Address
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Ward 42
Aberdeen Royal Infirmary
Foresterhill
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City/town
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Aberdeen
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Zip/Postcode
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AB25 2ZN
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Country
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United Kingdom
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Sponsor
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NHS Grampian Endowments (UK)
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Address
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NHS Grampian Endowments,
Research & Development Department,
Foresterhill House Annexe,
Foresterhill
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City/town
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Aberdeen
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Zip/Postcode
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AB25 2ZB
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Country
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United Kingdom
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Tel
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+44 (0)131 244 2246
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Fax
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+44 (0)131 244 2285
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Email
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Date applied
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14/06/2010
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Last edited
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13/10/2011
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Date ISRCTN assigned
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29/07/2010
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