Hysteroscopic Morcellator Versus Electrosurgical Resection for Submucosal Leiomyoma

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One of the most common reasons for presentation to a gynaecologist is for abnormal uterine bleeding (AUB). Women suspected for leiomyomas clinically or on ultrasound evidence are likely to be recommended to have surgical treatment for their condition, since medical treatment is ineffective for this presentation. Monopolar electrosurgical resection is frequently used in hysteroscopic removal of fibroids. Main complications include electrolyte disturbances and potential fatal outcomes due to use of hypotonic, non-conductive media (glycine) for uterine distension; and need for removal of the hysteroscope mid-procedure in order to clear the intrauterine cavity of debris, increasing operating time and potentiates cervical trauma. The hysteroscopic morcellator (Myosure (registered trademark)) has become an increasingly used tool to remove submucosal leiomyomas, as well as other intra-uterine pathology such as retained placental remnants. This instrument operates in a normal saline medium, removing the risk of hyponatraemia second to excessive absorption, during mechanical resection and concurrent removal of the fibroid from the intra-uterine cavity. Risk to the patient of fluid overload due to intra-vascular or intra-peritoneal absorption of large quantities of saline may occur. This study will compare the use of a mechanical hysteroscopic morcellator to monopolar electrosurgical hysteroscopic resection to remove submucosal leiomyomas in symptomatic women with AUB-L. We hypothesise that the hysteroscopic morcellator will allow for significantly faster resection of fibroids independent of surgical skill. The primary outcome of the study will investigate cost minimisation of the two different devices in an operating room setting, and determine opportunities for direct and indirect savings in a public health setting. Secondary outcomes will include determining: (1) ease of use of device; (2) completeness of resection, in terms of cessation of operation due to fluid deficit point being reached; and (3) the number of adverse events. This study is a prospective, randomised, single-blinded multi-centre clinical study. Women will be randomised to one of two study groups: 1. Intervention group: Resection of the leiomyoma with the hysteroscopic morcellator (Myosure (registered trademark)) and a normal saline distension medium. 2. Control group: Resection of the leiomyoma with a monopolar electrosurgical hysteroscopic resector with a glycine distension medium. Randomisation will occur via a third-party randomisation service, and study participants only will be blinded with regards to group allocation. A minimum of 162 participants to be enrolled over a 1-year recruitment period. All cases must satisfy the inclusion/exclusion criteria and will be followed for a minimum of 6 months after surgery.

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