Laparoscopic Radiofrequency Ablation of Uterine Leiomyomas: Clinical Outcomes during Early Adoption into Surgical Practice |
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| Affiliation: | 1. Division of Gynecology, Mayo Clinic, Rochester, Minnesota;2. University of Toronto, Toronto, Canada;3. University of São Paulo, São Paulo, Brazil;4. Royal Devon and Exeter NHS Trust, Exeter, United Kingdom;5. Department of Surgery, Carolinas Medical Center, Charlotte, North Carolina;1. Departments of Gynecological Surgery (Drs. Chauvet, Bourdel, and Canis);2. Medical Imaging (Drs. Magnin and Teluob);3. Clermont-Ferrand University Hospital Estaing, EnCoV, IP, UMR 6602 CNRS (Drs. Chauvet, Bourdel, Calvet, Magnin, Canis, and Bartoli);4. Department of Anatomy, Medecine Faculty (Dr. Magnin), Université Clermont Auvergne, Clermont-Ferrand, France;1. Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital at Linkou, Taoyuan, Taiwan (Drs. Y.-T. Huang, Wu, Su and Wang);2. Chang Gung University College of Medicine, Taoyuan, Taiwan (Drs. Wu and Wang);3. Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital, Taipei, Taiwan (Dr. H.-Y. Huang) |
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| Abstract: | Study ObjectiveTo assess surgical outcomes, clinical effectiveness, and gynecologist experience of introducing laparoscopic radiofrequency ablation (RFA) of leiomyomas into surgical practice.DesignUncontrolled clinical trial.SettingFive academic medical centers across California.PatientsPremenopausal women with symptomatic uterine leiomyomas, uterus size ≤16 weeks size, and all leiomyomas ≤10 cm with no more than 6 total leiomyomas.InterventionsLaparoscopic RFA of leiomyomas.Measurements and Main ResultsWe 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.ConclusionLaparoscopic 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. |
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