Clinical outcomes and health care utilization pre- and post-laparoscopic radiofrequency ablation of symptomatic fibroids and laparoscopic myomectomy: a randomized trial of uterine-sparing techniques (TRUST) in Canada

Abstract

ObjectiveThe objective of this study was to compare laparoscopic ultrasound-guided radiofrequency ablation of fibroids (Lap-RFA) and laparoscopic myomectomy in terms of 1) health care utilization and 2) serious complication rates. The secondary objectives were comparison of subject responses to validated symptom and quality-of-life questionnaires. We hypothesized that Lap-RFA health care utilization and clinical outcomes would not be worse than those of laparoscopic myomectomy in the aggregate.Patients and methodsPost-market, randomized, prospective, multicenter, longitudinal, non-inferiority interventional comparative evaluation of health care utilization and clinical outcomes in premenopausal women with symptomatic uterine fibroids who desired uterine conservation was conducted. Both procedures were planned as outpatient day surgeries. Health care resource utilization was measured during the procedure day and at 1 week, 1 and 3 months post-surgery. Symptom severity and quality of life were based on patients’ responses to the Uterine Fibroid Symptom Severity and Quality-of-Life Questionnaire, EuroQol-5D-visual analog scale general health status and menstrual impact questionnaires, and time from work.ResultsForty-five participants provided written informed consent and were enrolled (Lap-RFA, n=23; myomectomy, n=22) in Canada. Hospitalization time (primary endpoint) was 6.7±3.0 hours for the Lap-RFA group and 9.9±10.7 hours for the myomectomy group (Wilcoxon, p=0.0004). Intraoperative blood loss was lesser for Lap-RFA subjects: 25.2±21.6 versus 82.4±62.5 mL (p=0.0002). Lap-RFA procedures took lesser time than myomectomy procedures: 70.0 versus 86.5 minutes (p=0.018), and Lap-RFA required −34.9% (130 fewer) units of surgical equipment. At 3 months, both cohorts reported the same significant symptom severity reduction (−44.8%; p<0.0001). Lap-RFA subjects also took lesser time from work: 11.1±7.6 versus 18.5±10.6 days (p=0.0193). One myomectomy subject was hospitalized overnight after experiencing a 20-second asystole during the procedure. One Lap-RFA subject underwent a reintervention. The combined per patient direct and indirect costs of the two procedures were comparable: Lap-RFA (CAD $5,224.96) and myomectomy (CAD $5,321.96).ConclusionCompared to myomectomy, Lap-RFA is associated with significantly lesser intraoperative blood loss, shorter procedure and hospitalization times, lesser consumption/use of disposable and reusable surgery equipment, reduced health care resource utilization, and faster return to work through 3 months posttreatment. Direct and indirect costs of Lap-RFA and myomectomy are comparable.

Clinical Performance of Radiofrequency Ablation for Treatment of Uterine Fibroids: Systematic Review and Meta-Analysis of Prospective Studies

“…Lim et al 5 reported that laparoscopic Bongers et al 15 39 -23 -4.4 -3.1 -Brölmann et al 16 Garza-Leal 17 ----Braun et al 18 114 -60 6.8 -3.2 --Brucker et al 19 66 -24 10.0 -5.5 20.5 (5, 103) a 10.0 (2, 86) a Hahn et al 20 Krämer et al 21 Carrafiello et al 22 20 (15, 25) b ---Cho et al 23 -(10, 40) ---Cho et al 24 ----Chudnoff et al 25 126 -60 -9.0 (2, 60) a 5.0 (0, 29) a Galen et al 26 Guido et al 27 Berman et al 28 Chudnoff et al 29 47 -30 2. 30 Galen et al 31 140 (42, 290) a -4.5 (1, 11) b 4.0 (2, 10) a Garza-Leal et al 32 Robles et al 33 Ghezzi et al 34 25 (20, 45) a 18 c --Bergamini et al 35 Iversen and Dueholm 36 ----Iversen et al 37 Jiang et al 38 25 (20, 30) b ---Kim et al 39 18 -5 ---Lee et al 40 ----Marcos et al 41 36 -11 12.0 (8, 24) b --Meng et al 42 ----Rattray et al 43 73 -26 6.7 -3.0 -11.1 -7.6 Rey et al 44 17 (11, 44) b ---Turtulici et al 45 28 (16, 43) b ---Wu et al 46 -(20, 40) 2.5 c --…”

Non-extirpative Treatments for Uterine Myomas: Measuring Success

“…1 [14−35]. Nonextirpative treatments included UAE (16 studies, n = 9555) [14−17,19,20,22−24,26−29, 31,33,34], FUS (4 studies, n = 1516) [16,18,30,35], and laparoscopic RFA (3 studies, n = 49) [21,25,32]. UAE, FUS, and laparoscopic RFA groups were compared with patients undergoing myomectomy (n = 34872, n = 20667, n = 47 for each comparison respectively) [14−35].…”

“…Data regarding quality of life as determined with the UFS-QOL were provided in 4 studies, 2 comparing UAE with myomectomy [26,34] and 2 comparing laparoscopic RFA with myomectomy [25,32]. Using this scale, higher scores indicate better quality of life.…”

Uterine Fibroids and Infertility

“…The relationship between RFA and infertility is rarely the focus [72]. However, individual papers address case reports comparing pregnancy rates after RIF with those after surgical treatment and find similar outcomes concerning pregnancy, live birth, and abortion rates [70,73].…”