RESUMEN
OBJECTIVE: To compare 24-month patient-reported outcomes following laparoscopic radiofrequency volumetric thermal ablation (RFVTA) and laparoscopic myomectomy in patients with uterine fibroids. METHOD: An interim analysis of 24-month follow-up data from a randomized controlled trial was performed at Tübingen University Women's Hospital between November 1, 2012 and May 30, 2015. Premenopausal patients, at least 18years of age, who were menstruating, were randomly assigned to be treated for symptomatic uterine fibroids with either RFVTA or laparoscopic myomectomy. The outcomes included in the present per-protocol analysis were patients' responses to validated questionnaires and long-term safety. RESULTS: The study enrolled 51 patients; 21 and 22 patients in the RFVTA and laparoscopic myomectomy groups, respectively, completed 24months of follow-up. Improvements in the severity of symptoms from baseline were reported by participants in both the RFVTA (P<0.001) and laparoscopic myomectomy groups (P=0.001). A significant improvement in health-related quality of life was observed in the laparoscopic myomectomy group (P=0.040); a non-significant improvement was recorded in the RFVTA group (P=0.083). A trocar-site hematoma occurred in one patient in the laparoscopic myomectomy group. Further surgical interventions were recorded in three patients in the RFVTA group but these were unrelated to fibroid symptoms. CONCLUSIONS: These 24-month data suggest equivalence in safety and patient-reported efficacy of RFVTA and laparoscopic myomectomy. ClinicalTrials.gov:NCT01750008.
Asunto(s)
Técnicas de Ablación Endometrial/métodos , Laparoscopía/métodos , Leiomioma/cirugía , Miomectomía Uterina/métodos , Neoplasias Uterinas/cirugía , Adulto , Técnicas de Ablación Endometrial/efectos adversos , Femenino , Alemania , Humanos , Estudios Longitudinales , Menorragia/etiología , Persona de Mediana Edad , Premenopausia , Estudios Prospectivos , Calidad de Vida , Encuestas y Cuestionarios , Resultado del Tratamiento , Miomectomía Uterina/efectos adversosRESUMEN
OBJECTIVE: To compare the mean hospital discharge times and perioperative outcomes for radiofrequency volumetric thermal ablation (RFVTA) of fibroids and laparoscopic myomectomy (LM). METHODS: The present postmarket, randomized, prospective, single-center, longitudinal, comparative study, conducted in Tübingen, Germany, evaluated the outcomes of RFVTA and the current standard of care (LM) for symptomatic uterine fibroids in women who desired uterine conservation. The surgeons were blinded to the treatment until all fibroids had been mapped by laparoscopic ultrasound. RESULTS: The mean hospitalization times were 10.0 ± 5.5 (median 7.8 [range 4.2-25.5]) hours for the RFVTA group and 29.9 ± 14.2 (median 22.6 [range 16.1-68.1]) hours for the LM group (P < 0.001, Wilcoxon test). Intraoperative blood loss was 16 ± 9 (median 20 [range: 0-30]) mL for the RFVTA procedures and 51 ± 57 (median 35 [range 10-300]) mL for the LM procedures. The percentage of fibroids imaged by laparoscopic ultrasound that were treated/excised was 98.6% for RFVTA and 80.3% for LM. Two complications were reported: vertigo (n = 1; RFVTA) and port site hematoma (n = 1; LM). CONCLUSION: Radiofrequency volumetric thermal ablation resulted in the treatment of more fibroids, a significantly shorter hospital stay, and less intraoperative blood loss than laparoscopic myomectomy. ClinicalTrials.gov:NCT01750008.
Asunto(s)
Ablación por Catéter/métodos , Laparoscopía/métodos , Miomectomía Uterina/métodos , Neoplasias Uterinas/cirugía , Adulto , Pérdida de Sangre Quirúrgica , Femenino , Alemania , Humanos , Leiomioma/cirugía , Tiempo de Internación/estadística & datos numéricos , Estudios Longitudinales , Persona de Mediana Edad , Tratamientos Conservadores del Órgano/métodos , Estudios Prospectivos , Resultado del Tratamiento , Neoplasias Uterinas/patología , Útero/cirugíaRESUMEN
OBJECTIVES: To analyze characteristic features and details on motor-evoked potentials (MEPs) of the cricothyroid and vocalis muscles from single-pulse cortical transcranial magnetic stimulation (TMS) in normal subjects to characterize cortical motor representation of laryngeal muscles. STUDY DESIGN: Prospective, experimental investigation on healthy volunteers. METHOD: MEPs of the cricothyroid and vocalis muscles elicited by cortical TMS with a figure-8-shaped coil were investigated in two groups of six healthy subjects each, with special regard to MEP amplitude as a function of the coil position on the head surface along the interaural line. RESULTS: Bilateral reproducible responses of the cricothyroid and the vocalis muscles could be observed in all subjects. For the cricothyroid muscle, maximal responses were obtained at mean stimulus positions of 7.5 +/- 1.4 cm (contralateral) and of 7.3 +/- 1.3 cm (ipsilateral), respectively. For the vocalis muscle, we found maximal responses at mean stimulus positions of 10.3 +/- 1.9 cm (contralateral) and of 9.6 +/- 1.6 cm (ipsilateral), respectively. Despite a considerable overlap of these coil positions, from which reproducible MEPs could be elicited in both groups of the laryngeal muscles, statistically significant separation of the cricothyroid-and vocalis-associated cortical representation areas was possible. CONCLUSIONS: Our observations point to two different cortical motor representation areas, with the cricothyroid muscle-related area being located more medially.