The Trust (Treatment Results of Uterine Sparing Technologies) Study
Uterine fibroids are the most common pelvic neoplasms in women; they severely impact quality
of life and are the leading indication for hysterectomy. Hysterectomy is the definitive
treatment for myomas; however, many patients seek alternative uterine-sparing therapy and
desire to conserve their fertility. Myomectomy is a much-reported surgical option for women
with symptomatic fibroids and, until recently, the abdominal approach has been the approach
of choice for most surgeons. Over time, patients have requested less invasive procedures and
minimally invasive, laparoscopic options are becoming more popular among patients and their
gynecologists. Standard surgical and interventional treatments for uterine fibroids are
costly to society and to the health care system. New technologies such as GFA may offer a
low-cost alternative to the standard treatments for symptomatic uterine fibroids in women
who desire uterine conservation. This study seeks to evaluate those cost differences between
three available uterine-sparing techniques and to explore the qualitative outcomes such as
symptom severity, health related quality of life, and overall treatment effect.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Compare direct cost of GFA compared to those of myomectomy and UAE
To compare medical, surgical, and hospitalization costs (including procedural complication costs) of Global Fibroid Ablation (GFA) compared to those of Myomectomy and Uterine Artery Embolization (UAE)at 3 months post procedure.
3 months post procedure
No
Togas Tulandi, MD
Principal Investigator
McGill University
Canada: Ethics Review Committee
CP-00-0015
NCT01563783
December 2012
December 2019
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