Abstract

The objective of this paper was to assess the feasibility and efficacy of the NovaSure™ endometrial ablation system in the outpatient setting using local anaesthesia and to compare this with the standard day-case procedure under general anaesthesia. A prospective cohort-controlled study was undertaken at a university teaching hospital. The patient cohort was made up of 38 women with heavy menstrual bleeding refractory to medical therapy where endometrial ablation was indicated. Endometrial ablation using the NovaSure™ impedance-controlled ablative system was undertaken to compare outpatient treatment using local cervical anaesthetic (experimental group, n=18) with inpatient treatment under general anaesthesia (control group, n=20). The subjective self-assessment of uterine bleeding symptoms, patient satisfaction and health-related quality of life (HRQL; multi-attribute utility assessment) measures at six months following treatment were noted. Participants were also asked as to whether they would subsequently recommend the treatment, based on their experience. All procedures were successfully accomplished. Completed outcome questionnaires were returned by 17/18 (94%) women treated as outpatients and by 13/20 (65%) as inpatients. Overall, 27/30 (90%) women reported an improvement in menstrual bleeding symptoms, with an amenorrhoea rate of 37% (95% CI 20–56%) and a combined amenorrhoea/spotting rate of 53% (95% CI 34–72%). There was no significant difference between the outpatient and inpatient treatment groups in terms of improvement in menstrual blood loss (94% vs. 84%, P=0.6), amenorrhoea (29% vs. 46%, P=0.5), amenorrhoea/spotting (47% vs. 62%, P=0.5), satisfaction (82% vs. 85%, P=1.0), improvement in HRQL (P=0.3) and treatment setting recommendation (88% vs. 77%, P=0.7). From our results, we conclude that NovaSure™ impedance-controlled endometrial ablation is an effective, safe and feasible treatment for heavy menstrual bleeding in both the outpatient and traditional inpatient settings. A choice of treatment settings should be offered to women suitable for this procedure.

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