Blind versus visual endometrial ablation: a randomised controlled trial
| ISRCTN | ISRCTN43442156 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43442156 |
| Secondary identifying numbers | N/A |
- Submission date
- 14/06/2010
- Registration date
- 29/07/2010
- Last edited
- 04/07/2016
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Ward 42
Aberdeen Royal Infirmary
Foresterhill
Aberdeen
AB25 2ZN
United Kingdom
Study information
| Study design | Double-blind randomised active-controlled parallel-group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| Scientific title | Patient satisfaction, menstrual outcome and costs following blind versus visual second-generation ablation for the treatment of menorrhagia: a randomised controlled trial |
| Study objectives | 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(s) | NHS Grampian Ethics Committee - approval pending |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 10/01/2012 |
| Completion date | 10/01/2017 |
| Reason abandoned (if study stopped) | Lack of funding/sponsorship |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 220 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 10/01/2012 |
| Date of final enrolment | 10/01/2017 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
AB25 2ZN
United Kingdom
Sponsor information
Government
NHS Grampian Endowments
Research & Development Department
Foresterhill House Annexe
Foresterhill
Aberdeen
AB25 2ZB
United Kingdom
| Phone | +44 (0)131 244 2246 |
|---|---|
| abc@email.com | |
"ROR" |
https://ror.org/00ma0mg56 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
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)'.
