Sara Y Brucker1, Markus Hahn2, Dorit Kraemer1, Florin Andrei Taran1, Keith B Isaacson3, Bernhard Krämer1. 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, USA; Harvard Medical School, Boston, USA.
Abstract
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.
RCT Entities:
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.
Authors: M W Beckmann; I Juhasz-Böss; D Denschlag; P Gaß; T Dimpfl; P Harter; P Mallmann; S P Renner; S Rimbach; I Runnebaum; M Untch; S Y Brucker; D Wallwiener Journal: Geburtshilfe Frauenheilkd Date: 2015-02 Impact factor: 2.915
Authors: M Hahn; S Brucker; D Kraemer; M Wallwiener; F-A Taran; C W Wallwiener; B Krämer Journal: Geburtshilfe Frauenheilkd Date: 2015-05 Impact factor: 2.915
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