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

Completed

• Conditions: Urological and Genital Diseases; Heavy menstrual bleeding; Excessive, frequent and irregular menstruation

• Registration Number: ISRCTN45882141
• Lead Sponsor: HS Grampian (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12-10
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 263

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

Unwilling to complete follow-up

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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