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Type: Journal article
Title: Five-year follow up of a randomised controlled trial comparing NovaSure and ThermaChoice endometrial ablation
Author: Kleijn, J.
Engels, R.
Bourdrez, P.
Mol, B.
Bongers, M.
Citation: BJOG: an International Journal of Obstetrics and Gynaecology, 2008; 115(2):193-198
Publisher: Wiley
Issue Date: 2008
ISSN: 1470-0328
Statement of
JH Kleijn, R Engels, P Bourdrez, BWJ Mol, MY Bongers
Abstract: Objective:  We have previously reported that NovaSure® was more effective than balloon ablation at 12 months follow up in the treatment of menorrhagia. In this paper, we report the 5-year outcome of this study. The objective was to evaluate amenorrhoea rates, hysterectomy rate, and quality of life associated with the bipolar impedance-controlled endometrial ablation technique (NovaSure) in comparison with balloon ablation technique (ThermaChoice®) at 5 years after administration. Design:  Double-blind randomised controlled trial, 2:1 randomisation NovaSure versus ThermaChoice. Setting:  A teaching hospital with 500 beds in the Netherlands. Population:  A total of 126 premenopausal women suffering from menorrhagia with a pictorial blood loss assessment count ≥150 without intracavitary abnormalities. Methods:  Women were randomly allocated to bipolar radio-frequency ablation and balloon ablation in a 2:1 ratio. Main outcome measures:  The main outcome measures were amenorrhoea rate, hysterectomies, and health-related quality of life (HRQol) as reported at 5 year follow up. Results:  At 5 years of follow up, the total response rate was 96% in the bipolar group and 90% in the balloon group. Amenorrhoea was reported in the bipolar group by 48% of women and in the balloon arm by 32% (relative risk 1.6 [.93–2.6]). There were eight women in the bipolar group (9.8%) and five in the balloon group (12.9%) who had undergone a hysterectomy. Furthermore, there was a significant equal improvement of HRQoL over time in both groups. Conclusions:  At 5 years follow up, bipolar thermal ablation was superior over balloon ablation in the treatment of menorrhagia.
Keywords: Ablation; endometrial; long follow-up; menorrhagia; second generation ablation technique
Description: Article first published online: 6 JUL 2007
Rights: © 2007 The Authors
DOI: 10.1111/j.1471-0528.2007.01427.x
Appears in Collections:Aurora harvest 2
Obstetrics and Gynaecology publications

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