ABSTRACT
OBJECTIVE: The 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 METHODS: Post-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. RESULTS: Forty-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). CONCLUSION: Compared 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.
ABSTRACT
PURPOSE: Successful adoption of a new surgical procedure varies among practicing surgeons, and skill acquisition depends on the surgeon's innate ability, the complexity of the technique, and training. We report intraoperative and near-term postoperative outcomes from the Acessa procedure conducted by minimally invasive gynecologic surgeons new to Acessa, and report the surgeons' experiences during the training period. PATIENTS AND METHODS: The study was designed as a postmarket, prospective, single-arm, multicenter analysis of operative and early postoperative outcomes after proctored surgical training with the Acessa device and procedure (laparoscopic ultrasound-guided radiofrequency volumetric thermal ablation of symptomatic fibroids) in premenopausal, menstruating women as conducted in community and university hospitals in the USA and Canada. Surgeons completed evaluation forms once they felt they could safely and comfortably conduct the operations. RESULTS: Ten gynecologic surgeons without prior Acessa experience completed 40 Acessa procedures - all on an outpatient basis. Mean procedure time was 1.9±1.0 hours and was similar to that reported in the pivotal premarket study (2.1±1.0 hours). Two intraoperative complications occurred: a 1 cm uterine serosal laceration due to uterine manipulation and blood loss from both the probe insertion site and the lysis of uterine-omental adhesions. No postoperative complications or reinterventions for fibroid symptoms were reported. The surgeons completed the evaluation forms after two to five cases, and none found any factors affecting procedure efficiency to be inferior or needing improvement. CONCLUSION: Minimally invasive gynecologic surgeons new to Acessa can perform the procedure and provide acceptable outcomes after two to five proctored cases.
