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Interim analysis of a randomized controlled trial comparing laparoscopic radiofrequency volumetric thermal ablation of uterine fibroids with laparoscopic myomectomy
Author(s) -
Krämer Bernhard,
Hahn Markus,
Taran FlorinAndrei,
Kraemer Dorit,
Isaacson Keith B.,
Brucker Sara Y.
Publication year - 2016
Publication title -
international journal of gynecology and obstetrics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.895
H-Index - 97
eISSN - 1879-3479
pISSN - 0020-7292
DOI - 10.1016/j.ijgo.2015.10.008
Subject(s) - medicine , uterine myomectomy , uterine fibroids , randomized controlled trial , interim analysis , laparoscopy , surgery , adverse effect , myoma , uterus
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 18 years 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 24 months 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