RESUMEN
OBJECTIVE: To evaluate the 12-month safety and effectiveness of transcervical ablation for the treatment of symptomatic uterine leiomyomas. METHODS: In this prospective, multicenter, single-arm interventional trial, transcervical ablation was performed on 1-10 leiomyomas per patient with leiomyoma diameters ranging from 1 to 5 cm. Treated leiomyomas included all nonpedunculated types. Coprimary endpoints assessed at 12 months were reduction in menstrual blood loss and absence of surgical reintervention. Additional assessments included symptom severity, quality of life, patient satisfaction, reductions in uterine and leiomyoma volumes, and safety. RESULTS: One hundred forty-seven patients were enrolled and treated in the United States and Mexico. The study met its coprimary endpoints at 12 months (N=143; full analysis set), because 64.8% of patients (95% CI 56.3-72.6%) experienced 50% or greater reduction in menstrual bleeding and 99.3% of patients (95% CI 95.1-99.9%) were free from surgical reintervention. The mean pictorial blood loss assessment chart score decreased by 38.9%, 48.4%, and 51.1% at 3, 6, and 12 months, respectively (P<.001), and 95.1% of patients experienced a reduction in menstrual bleeding at 12 months. There were significant mean improvements in symptom severity and health-related quality of life of 32.1 points and 43.7 points, respectively, at 12 months (all P<.001). Mean maximal leiomyoma volume reduction per patient was 62.4% (P<.001). More than half of patients returned to normal activity within 1 day, 96.3% of patients reported symptom improvement at 12 months, and 97% expressed satisfaction with the treatment at 12 months. There were no device-related adverse events. CONCLUSION: Transcervical ablation was associated with a significant reduction in leiomyoma symptoms with no device-related adverse events and a low surgical reintervention rate through 12 months, demonstrating its potential to safely and effectively treat all nonpedunculated leiomyoma types through a uterus-conserving, incisionless approach. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02228174. FUNDING SOURCE: Supported by Gynesonics, Inc.
Asunto(s)
Ablación por Catéter , Leiomioma/cirugía , Ultrasonografía Intervencional , Neoplasias Uterinas/cirugía , Adulto , Cuello del Útero , Femenino , Humanos , México , Persona de Mediana Edad , Complicaciones Posoperatorias , Estudios Prospectivos , Reoperación , Estados UnidosRESUMEN
OBJECTIVE: To assess the effectiveness of an educational program in visual inspection with acetic acid (VIA) for cervical cancer screening among healthcare providers in 2 low-resource countries. METHODS: A cohort of multidisciplinary healthcare workers in Uganda and El Salvador were recruited to the study. A pretest was administered before the intervention of a 5-day educational program on VIA. A posttest was performed immediately after the educational program and again at a 6-month follow-up visit to assess retention of knowledge. RESULTS: In total, 42 (93%) of the healthcare workers who participated in the educational program completed the initial posttest evaluation, and 18 (40%) healthcare workers completed the 6-month follow-up evaluation. Mean test scores increased after participation in the training session (62% versus 81%; P<0.001). The self-reported comfort level for identifying cellular abnormalities also increased (2.1 versus 3.3; P<0.001). At 6-month follow-up, the mean test score remained higher than pretest scores (79% versus 57%; P<0.001). There was no significant difference in the initial and 6-month posttest scores (80% versus 79%; P=0.20). CONCLUSION: The educational program in VIA provided healthcare workers with the tools potentially to decrease the morbidity and mortality of cervical cancer in the 2 low-resource countries.