Hysteroscopic Morcellator versus Electrosurgical resection for Submucosal Leiomyoma

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This study will compare the use of a mechanical hysteroscopic morcellator to monopolar electrosurgical hysteroscopic resection to remove submucosal fibroid in symptomatic women. We hypothesize the hysteroscopic morcellator may reduce intraoperative time and allow additional procedures to be performed in a single operating list. The primary outcome of this study is to determine the difference if there is a difference in cost between two devices used to to resect the leiomyomas. As the operating time will is the most likely to have an impact on this, the time to resect intrauterine pathology between these two different instruments, from insertion of the hysteroscope to removal of instrumentation will form part of this primary outcome. Secondary outcomes include: Fluid deficit, Completeness of resection, and adverse events This is a prospective, randomised, single blinded study, with a minimum of 162 patients to be enrolled over a 1year recruitment period. All cases must satisfy the inclusion/exclusion criteria and will be followed for 6 months after surgery. Following decision to list a woman for a hysteroscopy and resection of fibroid, women will be considered for the study and offered participation. Women who qualify will be randomised to one of two groups: Hysteroscopic morcellator (Myosure, Registered trademark) with normal saline distension medium or monopolar electrosurgical hysteroscopic resector with a glycine distension medium. To ensure concealment, randomisation of women into treatment groups will occur via phone to an automated randomisation service. At the time of surgery, a diagnostic hysteroscopy will first be performed to confirm requirement for resection of a fibroid. Those that do not require resection will continue to have outcome data collected during the operation and followup but will not be included in analysis. Data collection will occur at: recruitment, on the day of admission for surgery and intraoperatively, postoperative review at 6 weeks after index surgery, and postoperative review at 6 months after index surgery. An economic evaluation will be conducted to determine the relative costs and benefits of hysteroscopic morcellation versus electrosurgical resection.

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