title: Radiofrequency Volumetric Thermal Ablation of Fibroids and Laparoscopic Myomectomy: Long-Term Follow-up From a Randomized Trial.
abstract: Aims:Laparoscopic myomectomy (LM) has been the gold standard treatment for uterine fibroids in women desiring uterine conservation. To evaluate a new fibroid treatment modality - radiofrequency volumetric thermal ablation (RFVTA) - we compare 12-month results in women who had symptomatic uterine fibroids and who were randomized to laparoscopic ultrasound-guided RFVTA or LM.Materials and Methods:Our study is a 1 : 1 parallel, randomized, prospective, single-center, longitudinal, comparative analysis of RFVTA to LM for fibroid treatment in women ≥ 18 years of age who desired uterine conservation. Fifty women were randomized intraoperatively to RFVTA (n = 25) or to LM (n = 25) after laparoscopic ultrasound mapping of the uterus.Results:Post surgery, ablation and myomectomy subjects took pain medications for 4 days (range: 1-46) and 7 days (range: 1-83 days) respectively (p = 0.60). Ablation and myomectomy subjects missed 10.0 workdays (range: 2-86 days) and 17.0 workdays (range: 7-30 days) (p = 0.28), resumed normal activities in 20.5 days (range: 5-103 days) versus 28.0 days (range: 10-42 days) (p = 0.86) respectively. Mean symptom severity scores decreased (improved) by - 7.8 for the ablation subjects and by - 17.9 for the myomectomy subjects (p = 0.16). Health-related quality of life improved (increased) by 7.5 and 13.1, respectively, for the two groups (p = 0.46). Two myomectomy subjects had pregnancies that ended in a Cesarean delivery and a vaginal delivery of healthy infants. Two pregnancies in the RFVTA group ended in full-term vaginal deliveries of healthy infants.Conclusions:Early postoperative recovery and twelve-month results attest to similar clinical benefits from RFVTA and LM.
authors.affiliation: Department of Obstetrics and Gynecology, University of Tübingen, Tübingen.
authors.forename: M
authors.initials: M
authors.lastname: Hahn
authors.affiliation: Department of Obstetrics and Gynecology, University of Tübingen, Tübingen.
authors.forename: S
authors.initials: S
authors.lastname: Brucker
authors.affiliation: Department of Obstetrics and Gynecology, University of Tübingen, Tübingen.
authors.forename: D
authors.initials: D
authors.lastname: Kraemer
authors.affiliation: Department of Obstetrics and Gynecology, University of Heidelberg, Heidelberg.
authors.forename: M
authors.initials: M
authors.lastname: Wallwiener
authors.affiliation: Department of Obstetrics and Gynecology, University of Tübingen, Tübingen.
authors.forename: F-A
authors.initials: FA
authors.lastname: Taran
authors.affiliation: Department of Obstetrics and Gynecology, University of Tübingen, Tübingen.
authors.forename: C W
authors.initials: CW
authors.lastname: Wallwiener
authors.affiliation: Department of Obstetrics and Gynecology, University of Tübingen, Tübingen.
authors.forename: B
authors.initials: B
authors.lastname: Krämer
keywords: Acessa; fibroids; laparoscopic myomectomy; laparoscopic ultrasound; radiofrequency volumetric thermal ablation