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| [ Print-friendly version ] |
| Hydrothermablator Endometrial Ablation versus Microwave Endometrial Ablation Trial: A trial comparing two methods of treating heavy periods to each other |
| ISRCTN | ISRCTN43442156 |
| ClinicalTrials.gov identifier | |
| Public title | Hydrothermablator Endometrial Ablation versus Microwave Endometrial Ablation Trial: A trial comparing two methods of treating heavy periods to each other |
| Scientific title | Hydrothermablator Endometrial Ablation versus Microwave Endometrial Ablation Trial: A randomised comparison of treatment in the postmenstrual phase, clinical outcomes, patient acceptability +/- and costs |
| Acronym | N/A |
| Serial number at source | N/A |
| 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 | IRAS Trial Application in progress. Local ethics committee is NHS Grampian Ethics Committee. |
| Study design | Double blind randomised active controlled parallel group trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Women's Health - Reproductive Disease. |
| Participants - 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 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 |
| Participants - exclusion criteria |
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 |
| Anticipated start date | 01/08/2010 |
| Anticipated end date | 01/08/2012 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use contact details below to request a patient information sheet |
| Target number of participants | 200 |
| Interventions |
Patients will be randomised in a 1:1 basis to either MEA or HTA 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.
MEA and HTA are both 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. |
| Primary outcome measure(s) | Patient satisfaction with each technique. Measured using a six point Linkert scale, post-operatively and at 6 and 12 months. |
| Secondary outcome measure(s) |
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. |
| Sources of funding | Chief Scientist Office (CSO) (UK) - Scottish Health Executive (application for research grant in progress) |
| Trial website | |
| Publications | |
| Contact name | Dr Kevin Cooper |
| Address |
Ward 42
Aberdeen Royal Infirmary Foresterhill |
| City/town | Aberdeen |
| Zip/Postcode | AB25 2ZN |
| Country | United Kingdom |
| Sponsor | Chief Scientist Office (CSO) (UK) |
| Address |
Chief Scientist Office for Scotland
Scottish Health Executive dept St Andrew's House Regents Road, Edinburgh |
| City/town | Edinburgh |
| Zip/Postcode | EH1 3D |
| Country | United Kingdom |
| Tel | +44 (0)131 244 2246 |
| Fax | +44 (0)131 244 2285 |
| karen.ford@scotland.gsi.gov.uk | |
| Sponsor website: | http://www.cso.scot.nhs.uk |
| Date applied | 14/06/2010 |
| Last edited | 29/07/2010 |
| Date ISRCTN assigned | 29/07/2010 |
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| © 2010 ISRCTN unless otherwise stated. | |
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