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?:abstract
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Study Objective To describe the experience of TFA with the Sonata® system in the ambulatory surgicenter (ASC) setting, relative to current recommendations by medical societies for elective procedures during the COVID-19 pandemic Design Prospective, longitudinal, multicenter controlled trial Setting 22 clinical sites in the US and Mexico Patients or Participants 147 premenopausal women between the ages of 25 and 50 with heavy menstrual bleeding secondary to nonpedunculated fibroids Interventions Transcervical, intrauterine ultrasound-guided radiofrequency ablation with the Sonata system Pain scores were recorded after each procedure using a scale from 0-10 Length of stay (LOS) was measured from procedure start through discharge Measurements and Main Results Of 147 treated patients, 49 were treated in an ASC setting and 98 were treated in other outpatient settings Fifty-five percent of patients treated in an ASC had general anesthesia and 45% had conscious sedation vs 48% and 52%, respectively for non-ASC population Average number of fibroids treated per patient was 3 2±2 0 and 2 9±2 1 in ASC and non-ASC, respectively Mean LOS was 2 1±0 9 hours vs 2 8±1 3 hours for ASC and non-ASC patients, respectively Mean procedure pain scores were 0±0% for the ASC patients (0 4±1 1 for non-ASC patients) Mean return to normal activity for patients treated in ASC was 1 7±1 4 days (2 4±2 5 for non-ASC patients) Mean 12-month improvements in SSS and HRQL scores were -34 8±23 9 and 48 6±26 2 points, respectively, in ASC patients (-30 4±19 3 and 41 0±23 0, respectively, in non-ASC patients) Conclusion Current surgical guidance during the COVID-19 pandemic encourages avoidance of endotracheal intubation when appropriate and minimizing exposure time for patients and staff Transcervical Fibroid Ablation with the Sonata system is performed without pneumoperitoneum or a requirement for intubation, providing short LOS, minimal pain scores and improved outcomes while potentially reducing risk to healthcare personnel and patients alike
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