J Minim Invasive Gynecol. 2022 Jan 24:S1553-4650(22)00037-1. doi: 10.1016/j.jmig.2022.01.009. Online ahead of print.
ABSTRACT
STUDY OBJECTIVE: The objective of this study was to determine the efficacy, safety, and healthcare resource utilization of laparoscopic radiofrequency ablation (LAP-RFA) compared to myomectomy in patients with symptomatic uterine leiomyomas (ULs).
DESIGN: This was a secondary analysis of the original post-market randomized, prospective, multi-center, longitudinal, comparative TRUST US trial in patients with symptomatic ULs. After the procedure, subjects were followed over a 12-month period.
SETTING: Multi-center trial, including hospitals with or without an academic affiliation, surgery centers, and fertility centers performing outpatient procedures for uterine fibroids 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) MAIN OUTCOME MEASURES: 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 (PRO) scores over time. Secondary outcomes included hospitalization post-procedure, length of stay, complications, reinterventions and recovery time.
RESULTS: There was a significant improvement in UL symptoms at 3- and 12-months post-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 post-procedure for both LAP-RFA and myomectomy of 72% and 85%, respectively. A significant improvement was seen in all PRO scores over time for both groups. At 3- and 12-months post-procedure, the percentages of patients who were hospitalized in the LAP-RFA group were 74% and 49% lower than laparoscopic myomectomy at 3 and 12 months, respectively, with the 3-month difference being statistically significant. The length of hospital stay was significantly lower in the LAP-RFA group compared to Myomectomy (8.0 ± 5.7 hours vs 18.8 ± 14.6 hours; p<0.05). Doctors recommended taking significantly less time off before returning to work in the LAP-RFA group compared to myomectomy (10.3 ± 5.1 days vs 14.5 ± 5.4 days, p<0.05) and the total days until back to normal activity was significantly lower in the LAP-RFA group compared to myomectomy (16.3 ± 15.2 days vs 26.5 ± 15.9 days, p<0.05).
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 utilization overall, including lower post-procedure hospitalization rate and length of stay. In clinical practice, LAP-RFA is a promising treatment approach to ULs for women.
TRIAL REGISTRATION: NCT02163525 (https://clinicaltrials.gov/ct2/show/NCT02163525) STUDY TYPE: Interventional (clinical trial) ENROLLMENT: 114 participants ALLOCATION: Randomized INTERVENTION MODEL: Parallel assignment MASKING: None (open label) PRIMARY PURPOSE: Treatment STUDY START DATE: June 2014 ACTUAL PRIMARY COMPLETION DATE: July 2019 ESTIMATED STUDY COMPLETION DATE: June 2024 DATA REPOSITORY: https://pfgmed.box.com/v/TRUSTDataRep.
PMID:35085837 | DOI:10.1016/j.jmig.2022.01.009
