Hysteroscopic Morcellator Versus Electrosurgical Resection for Submucosal Leiomyoma

INTERVENTION: Hysteroscopic Morcellation The MyoSure (Registered Trademark) is a 2nd‐generation hysteroscopic morcellation device. It aims to remove leiomyomas in one single insertion of a hysteroscope into the uterus . The device uses suction‐based, mechanical energy to rotate a morcellating system and concurrently aspirate tissue strips. The uterus is distended with saline via a small channel in the hysteroscope. This procedure, performed by the surgeon (consultant or supervised trainee), is intended to reduce risks of (1) traumatic injury to uterus and inadvertent fluid overload compared to traditional procedures, by reducing operation time; (2) thermal injury compared to thermal ablation techniques. Duration of this procedure is between 10 to 60 minutes. CONDITION: Submucosal Leiomyoma Uterine Fibroids PRIMARY OUTCOME: Cost‐utility of hysteroscopic morcellation vs. monopolar electrosurgical resection: Cost minimisation study of two devices in an operating room setting, so as to determine opportunities for direct and indirect savings in a public health setting ; ; We will assess total theatre time, opportunity cost and complete revision of pre‐operative, intra‐operative and post‐operative consumables and reusable items. Post‐operative visits, incidental medications, re‐interventions or complications will be coded and cost‐calculated according to MBS schedules in a prospective manner. SECONDARY OUTCOME: Completeness of resection: Determine need for cessation of operation due to fluid deficit point being reached, and as a result, the completeness of resection by the two devices. ; ; Completness of resection is reported by the surgeon following the procedure as a fraction of the remaining pathology. Cost‐benefit analysis dependent on clinical outcome data following hysteroscopic morcellation vs. monopolar electrosurgical resection: Cost‐effectiveness of clinical outcomes following hysteroscopic morcellation or monopolar electrosurgical resection; considering cost of post‐operative care including re‐presentation, follow‐up consultation, treatment of complications/adverse events, need for repeat procedures Ease of use of device: Investigate ease of use of hysteroscopic morcellation vs. electrosurgical resection, among surgeons of different skill levels (Trainee, Fellow, Consultant) ; ; Ease of use of the device will be assessed using a verbal descriptor scale. Number of adverse events: Determine frequency, severity and significance of adverse events which occur with both devices. ; ; Adverse events, such as bleeding, fluid overload, electrolyte imbalance, infection, and vaginal discharge, are assessed intra‐ and post‐operatively and are recorded and tracked in the specifically designed case report form for this study. These will be assessed by in‐person contact, searching patient case notes and communication with the local medical officer. INCLUSION CRITERIA: ‐ All symptomatic women requiring an elective hysteroscopic procedure for a suspected or ultrasound confirmed leiomyoma ‐ English speaking ‐ Over 18 years of age at time of surgery ‐ Women who understand the conditions of the study, and are willing to participate for the length of the prescribed term of follow‐up