Bernhard Krämer1, Markus Hahn2, Florin-Andrei Taran1, Dorit Kraemer1, Keith B Isaacson3, Sara Y Brucker1. 1. Department of Obstetrics and Gynecology, University of Tübingen, Tübingen, Germany. 2. Department of Obstetrics and Gynecology, University of Tübingen, Tübingen, Germany. Electronic address: Markus.hahn@med.uni-tuebingen.de. 3. Minimally Invasive Surgery, Newton-Wellesley Hospital, Newton, MA USA; Harvard Medical School, Boston, MA USA.
Abstract
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.
RCT Entities:
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.
Authors: Kelli M Braun; Mark Sheridan; Erin Z Latif; Lexy Regush; Anet Maksymowicz; Laura Weins; Mohamed A Bedaiwy; Nerissa Tyson; Marilyn J Davidson; Barry H Sanders Journal: Int J Womens Health Date: 2016-11-23