Blind versus visual endometrial ablation: a randomised controlled trial

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN43442156

Enrollment

220

Registered

2010-07-29

Start date

2012-01-10

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Women's health - reproductive disease Urological and Genital Diseases Excessive, frequent and irregular menstruation

Interventions

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

Eligibility

Sex/Gender

Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026