3 Committee considerations

3 Committee considerations

The evidence

3.1 NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 12 sources, which was discussed by the committee. The evidence included 2 systematic reviews, 2 randomised controlled trials (1 is also included in the systematic review and the other compares 2 different healthcare settings), 1 non-randomised comparative study, 3 cohort studies, 2 case series, 1 case report and 1 review of adverse events reported on the US Food and Drug Administration Manufacturer and User Facility Device Experience database. It is presented in the summary of key evidence section in the interventional procedures overview. Other relevant literature is in the appendix of the overview.

3.2 The professional experts and the committee considered the key efficacy outcomes to be: symptom relief, effective removal of fibroids and preservation of the ability to become pregnant.

3.3 The professional experts and the committee considered the key safety outcomes to be: bleeding, uterine perforation, infection and need for a hysterectomy.

3.4 Patient commentary was sought but none was received.

Committee comments

3.5 Hysteroscopic tissue removal (hysteroscopic morcellation) is a different procedure from laparoscopic morcellation, on which NICE has also produced guidance.

3.6 The committee was informed that hysteroscopic morcellation has a theoretical risk of disseminating malignant tissue through uterine perforation or retrograde flow through the fallopian tubes. The committee noted that this is a theoretical risk in contrast to the recognised risk of dissemination in laparoscopic morcellation of fibroids, in which the morcellation takes place within the peritoneal cavity.

3.7 The committee was informed that the procedure can be used for other indications, but this guidance is only for treatment of uterine fibroids.

3.8 The committee was informed that automated fluid management systems are used with some devices to reduce the risk of causing excessively high uterine pressures and subsequent fluid overload. It noted the guideline on management of fluid distension media in operative hysteroscopy published by the British Society for Gynaecological Endoscopy and the European Society for Gynaecological Endoscopy.

3.9 It is possible to take a biopsy of the fibroid before or during the procedure.

ISBN: 978-1-4731-4239-8

  • National Institute for Health and Care Excellence (NICE)