Hysteroscopic Morcellator Versus Electrosurgical Resection for Submucosal Leiomyoma

Not Applicable

Recruiting

• Conditions: Submucosal Leiomyoma; Uterine Fibroids; Renal and Urogenital - Other renal and urogenital disorders

• Registration Number: ACTRN12616001404415
• Lead Sponsor: GRACE Unit - School of Women's and Children's Health, UNSW Sydney, Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 162

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

Exclusion Criteria

- Pregnant women
- Immuno-compromised women
- Current involvement in any other research project
- Women who are suspected to have a gynaecological malignancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br><br>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. [Intra-operative]