학술논문

Periprocedural outcomes comparing fibroid embolization and focused ultrasound: a randomized controlled trial and comprehensive cohort analysis.
Document Type
article
Source
American journal of obstetrics and gynecology. 216(5)
Subject
Humans
Leiomyoma
Uterine Neoplasms
Pain
Postoperative
Analgesics
Opioid
Antiemetics
Anti-Inflammatory Agents
Non-Steroidal
Cohort Studies
Recovery of Function
Adult
Drug Utilization
Female
Magnetic Resonance Imaging
Interventional
Uterine Artery Embolization
Ultrasonic Surgical Procedures
Return to Work
Visual Analog Scale
focused ultrasound
leiomyoma
randomized controlled trial
uterine artery embolization
uterine fibroid
Contraception/Reproduction
Clinical Research
Fibroid Tumors (Uterine)
Pain Research
Clinical Trials and Supportive Activities
Patient Safety
Chronic Pain
Reproductive health and childbirth
Paediatrics and Reproductive Medicine
Obstetrics & Reproductive Medicine
Language
Abstract
BackgroundUterine fibroids are a common problem for reproductive-aged women, yet little comparative effectiveness research is available to guide treatment choice. Uterine artery embolization and magnetic resonance imaging-guided focused ultrasound surgery are minimally invasive therapies approved by the US Food and Drug Administration for treating symptomatic uterine fibroids. The Fibroid Interventions: Reducing Symptoms Today and Tomorrow study is the first randomized controlled trial to compare these 2 fibroid treatments.ObjectiveThe objective of the study was to summarize treatment parameters and compare recovery trajectory and adverse events in the first 6 weeks after treatment.Study designPremenopausal women with symptomatic uterine fibroids seen at 3 US academic medical centers were enrolled in the randomized controlled trial (n = 57). Women meeting identical criteria who declined randomization but agreed to study participation were enrolled in a nonrandomized parallel cohort (n = 34). The 2 treatment groups were analyzed by using a comprehensive cohort design. All women undergoing focused ultrasound and uterine artery embolization received the same postprocedure prescriptions, instructions, and symptom diaries for comparison of recovery in the first 6 weeks. Return to work and normal activities, medication use, symptoms, and adverse events were captured with postprocedure diaries. Data were analyzed using the Wilcoxon rank sum test or χ2 test. Multivariable regression was used to adjust for baseline pain levels and fibroid load when comparing opioid medication, adverse events, and recovery time between treatment groups because these factors varied at baseline between groups and could affect outcomes. Adverse events were also collected.ResultsOf 83 women in the comprehensive cohort design who underwent treatment, 75 completed postprocedure diaries. Focused ultrasound surgery was a longer procedure than embolization (mean [SD], 405 [146] vs 139 [44] min; P