4 Efficacy

4 Efficacy

This section describes efficacy outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.

4.1 A non‑randomised comparative study of 200 patients treated by hysteroscopic morcellation or conventional hysteroscopic resection reported that all patients were symptom free at 3‑month follow‑up.

4.2 A randomised controlled trial of 60 patients treated by hysteroscopic morcellation or conventional hysteroscopic resection reported mean operating times of 11 and 17 minutes, respectively (p=0.008). The non‑randomised comparative study of 200 patients treated by hysteroscopic morcellation or conventional hysteroscopic resection reported mean operating times of 16 minutes (95% confidence interval [CI] 13 to 20) and 42 minutes (95% CI 40 to 45) respectively (p value not stated).

4.3 The randomised controlled trial of 60 patients treated by hysteroscopic morcellation or conventional hysteroscopic resection reported mean total fluid deficits (the amount of distending fluid infused during a procedure minus the amount of fluid recovered) of 409 and 545 ml respectively (p=0.224). The non‑randomised comparative study of 200 patients treated by hysteroscopic morcellation or conventional hysteroscopic resection reported mean fluid deficits of 660 ml (95% CI 419 to 901) and 742 ml (95% CI 646 to 838) respectively (p value not stated).

4.4 The specialist advisers listed key efficacy outcomes as: proportion of leiomyoma (fibroid) removed by morcellator at first procedure, need for repeat procedures to remove leiomyoma remnants, relief of symptoms (such as reduction in menstrual blood loss and reduction or stopping of intermenstrual bleeding), need for further treatment (including surgery) to manage initial symptoms, reduction in incidence of miscarriage, duration of pregnancy, and live birth rate.

  • National Institute for Health and Care Excellence (NICE)