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A randomised comparison of microwave endometrial ablation with transcervical resection of the endometrium: follow-up at a minimum of ten years

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN45882141
Enrollment
263
Registered
2008-12-10
Start date
1995-12-11
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Heavy menstrual bleeding Urological and Genital Diseases Excessive, frequent and irregular menstruation

Interventions

Interventions: Microwave endometrial ablation (MEA™) vs transcervical resection of the endometrium (TCRE). Start date of RCT: 11/12/1995 End date of RCT: 01/12/1998 (end of follow-up) Follow-up st

Sponsors

NHS Grampian (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Premenopausal women, no age limits 2. Heavy menstrual loss 3. Family was complete (i.e. no desire for further children) 4. No endometrial atypia 5. Uterine size not greater than ten weeks size

Exclusion criteria

Exclusion criteria: Unwilling to complete follow-up

Design outcomes

Primary

MeasureTime frame
Patient satisfaction and acceptability of treatment, assessed by questionnaires (Timepoints: T1-T5). Timepoints: T0: Within 6 weeks after operation T1: 4 months after operation T2: 12 months after operation T3: Minimum of 2 years after operation T4: Minimum of 5 years after operation T5: Minimum of 10 years after operation Additional data were also obtained via a hospital database.

Secondary

MeasureTime frame
The following were assessed at timepoints T0-T5: 1. Menstrual symptoms (questionnaires) 2. Changes in health related quality of life, assessed by the SF-36 Health Survey 3. Additional treatments received (questionnaires) Timepoints: T0: Within 6 weeks after operation T1: 4 months after operation T2: 12 months after operation T3: Minimum of 2 years after operation T4: Minimum of 5 years after operation T5: Minimum of 10 years after operation Additional data were also obtained via a hospital database.

Countries

United Kingdom

Outcome results

None listed

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