Laparoscopic Radiofrequency Ablation of Uterine Leiomyomas: Clinical Outcomes during Early Adoption into Surgical Practice
| Autor: | L. Elaine Waetjen, Ram Parvataneni, Erica Oberman, Naghmeh S Saberi, Vanessa L. Jacoby, Michael Schembri, Shira Varon |
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| Rok vydání: | 2019 |
| Předmět: |
Adult
medicine.medical_specialty Radiofrequency ablation Operative Time California law.invention 03 medical and health sciences Young Adult 0302 clinical medicine Gynecologic Surgical Procedures Quality of life law medicine Humans Practice Patterns Physicians' Adverse effect Laparoscopy Intraoperative Complications Radiofrequency Ablation 030219 obstetrics & reproductive medicine medicine.diagnostic_test Leiomyoma business.industry Obstetrics and Gynecology Middle Aged medicine.disease Confidence interval Surgery Clinical trial surgical procedures operative Treatment Outcome 030220 oncology & carcinogenesis Uterine Neoplasms Quality of Life Education Medical Continuing Female Clinical Competence Sexual function business Learning Curve |
| Zdroj: | Journal of minimally invasive gynecology. 27(4) |
| ISSN: | 1553-4669 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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