1. Laparoscopic Radiofrequency Ablation of Uterine Leiomyomas: Clinical Outcomes during Early Adoption into Surgical Practice.
- Author
-
Jacoby VL, Parvataneni R, Oberman E, Saberi NS, Varon S, Schembri M, and Waetjen LE
- Subjects
- Adult, California epidemiology, Clinical Competence statistics & numerical data, Education, Medical, Continuing statistics & numerical data, Education, Medical, Continuing trends, Female, Humans, Intraoperative Complications epidemiology, Intraoperative Complications etiology, Laparoscopy adverse effects, Laparoscopy education, Laparoscopy statistics & numerical data, Learning Curve, Leiomyoma epidemiology, Leiomyoma pathology, Middle Aged, Operative Time, Practice Patterns, Physicians' statistics & numerical data, Practice Patterns, Physicians' trends, Quality of Life, Radiofrequency Ablation adverse effects, Radiofrequency Ablation statistics & numerical data, Treatment Outcome, Uterine Neoplasms epidemiology, Uterine Neoplasms pathology, Young Adult, Gynecologic Surgical Procedures education, Gynecologic Surgical Procedures methods, Gynecologic Surgical Procedures statistics & numerical data, Gynecologic Surgical Procedures trends, Laparoscopy methods, Leiomyoma surgery, Radiofrequency Ablation methods, Uterine Neoplasms surgery
- Abstract
Study Objective: To assess surgical outcomes, clinical effectiveness, and gynecologist experience of introducing laparoscopic radiofrequency ablation (RFA) of leiomyomas into surgical practice., Design: Uncontrolled clinical trial., Setting: Five academic medical centers across California., Patients: Premenopausal women with symptomatic uterine leiomyomas, uterus size ≤16 weeks 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 operative 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 previous 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 were enrolled. The mean age of the participants was 41.5 ± 4.9 years. The mean operating time was 153 ± 51 minutes, and mean estimated blood loss was 24 ± 40 cc. 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 ± 18-point, or 47%, decrease in the Leiomyoma Symptom Severity Score. After the first procedure, the mean difficulty score was 6 (95% 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 difficulty score decreased to 4.25 (95% CI, 1.2-6) after the fourth procedure, with all gynecologists reporting surgical confidence., Conclusion: Laparoscopic RFA of leiomyomas can be introduced into surgical practice with good clinical outcomes for patients. Gynecologists with no previous experience are able to gain confidence and skill with the procedure in fewer than 5 cases., (Copyright © 2019. Published by Elsevier Inc.)
- Published
- 2020
- Full Text
- View/download PDF