Laparoscopic Radiofrequency Ablation of Uterine Leiomyomas: Clinical Outcomes during Early Adoption into Surgical Practice.
- Author(s): Jacoby, Vanessa L
- Parvataneni, Ram
- Oberman, Erica
- Saberi, Naghmeh Salamat
- Varon, Shira
- Schembri, Michael
- Waetjen, L Elaine
- et al.
Published Web Locationhttps://doi.org/10.1016/j.jmig.2019.07.025
STUDY OBJECTIVE:To assess surgical outcomes, clinical effectiveness, and gynecologist's experience of introducing laparoscopic radiofrequency ablation (RFA) of leiomyomas into surgical practice. DESIGN:Uncontrolled clinical trial SETTING: 5 academic medical centers across California PATIENTS: Premenopausal women with symptomatic uterine leiomyomas, uterus ≤16 week size and all leiomyomas ≤10 cm with no more than 6 total leiomyomas. INTERVENTIONS:Laparoscopic RFA of leiomyomas. MEASUREMENTS AND MAIN RESULTS:We assessed intraoperative complications, blood loss, operative time, and adverse events. Gynecologists reported the difficulty and need for further training after each case. Participants reported leiomyoma symptoms preoperatively and at 6 and 12 weeks after surgery. We analyzed all outcome data from the first case performed by gynecologists with no prior RFA experience. Patient demand for RFA was high, but poor insurance authorization prevented 74% of eligible women from trial participation; 26 women underwent surgery and enrolled. The mean age of participants was 41.5 years (standard deviation (SD) 4.9). Mean operating time was 153 minutes (SD 51) and estimated blood loss was 24cc (SD 40). There were no intraoperative complications and no major adverse events. Menstrual bleeding, sexual function, and quality of life symptoms improved significantly from baseline to 12 weeks with a 25 point (SD 18), or 47% decrease in the leiomyoma Symptom Severity Score. After the first procedure performed, 6 was the mean difficulty score (Confidence Interval (CI) 4, 7.5) on a 10 point scale and 89% of surgeons felt "very or somewhat" confident in performing laparoscopic RFA; the score decreased to 4.25 (CI 1.2, 6) after the fourth procedure with all gynecologists reporting surgical confidence. CONCLUSIONS:Laparoscopic RFA of leiomyomas can be introduced into surgical practice with good clinical outcomes for patients. Gynecologists with no prior experience are able to gain confidence and skill with the procedure quickly in <5 cases.
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