Title

Clinical and Patient Reported Outcomes of Pre- and Postsurgical Treatment of Symptomatic Uterine Leiomyomas: A 12-Month Follow-up Review of TRUST, a Surgical Randomized Clinical Trial Comparing Laparoscopic Radiofrequency Ablation and Myomectomy

Document Type

Journal Article

Publication Date

1-24-2022

Journal

Journal of minimally invasive gynecology

DOI

10.1016/j.jmig.2022.01.009

Keywords

Gynecologic surgery; Healthcare resource utilization; Patient-reported outcomes; Quality of life; Uterine myomas

Abstract

STUDY OBJECTIVE: The objective of this study was to determine the efficacy, safety, and healthcare resource use of laparoscopic radiofrequency ablation (LAP-RFA) compared with myomectomy in patients with symptomatic uterine leiomyomas (ULs). DESIGN: This was a secondary analysis of the original postmarket randomized, multicenter, longitudinal, comparative TRUST (Treatment Results of Uterine Sparing Technologies) United States trial in patients with symptomatic ULs. After the procedure, subjects were followed over a 12-month period. SETTING: Multicenter trial, including hospitals with or without an academic affiliation, surgery centers, and fertility centers performing outpatient procedures for uterine myomas. PARTICIPANTS: A total of 57 patients were randomized to either LAP-RFA (n = 30) or myomectomy (n = 27). INTERVENTIONS: LAP-RFA or myomectomy (laparoscopic or abdominal). MEASUREMENTS AND MAIN RESULTS: The main outcome measures of this study were part of the secondary outcomes of the original TRUST trial. The primary outcome of this study was the reduction of UL symptoms and the improvement in patient-reported outcomes scores over time. Secondary outcomes included postprocedure hospitalization, length of stay, complications, reinterventions, and recovery time. There was a significant improvement in UL symptoms at 3 and 12 months after the procedure within each treatment group, and these improvements were similar between treatment groups. There was a significant reduction in UL symptoms per month between baseline and 12-months after the procedure for both LAP-RFA and myomectomy of 72% and 85%, respectively. A significant improvement was seen in all patient-reported outcomes scores over time for both groups. At 3 and 12 months after the procedure, the percentages of patients who were hospitalized in the LAP-RFA group were 74% and 49% lower than those of patients in the laparoscopic myomectomy group, respectively, with the 3-month difference being statistically significant. The length of hospital stay was significantly shorter in the LAP-RFA group compared with the myomectomy group (8.0 ± 5.7 hours vs 18.8 ± 14.6 hours; p < .05). Doctors recommended taking significantly less time off before returning to work for the patients in the LAP-RFA group compared with those in the myomectomy group (10.3 ± 5.1 days vs 14.5 ± 5.4 days; p < .05). The total number of days until back to normal activity was significantly lower in the LAP-RFA group compared with the myomectomy group (16.3 ± 15.2 days vs 26.5 ± 15.9 days; p < .05). CONCLUSION: The results from this 12-month follow-up study suggest that LAP-RFA is a safe, effective, uterine-sparing alternative to laparoscopic myomectomy in the treatment of ULs. These data points build on previously published studies showing that LAP-RFA has lower healthcare resource use overall, including lower postprocedure hospitalization rate and shorter length of stay. In clinical practice, LAP-RFA is a promising treatment approach to ULs for women.

Department

Obstetrics and Gynecology

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