Dataset Information

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.

SUBMITTER: Hahn M

PROVIDER: S-EPMC4461677 | biostudies-literature | 2015 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Radiofrequency Volumetric Thermal Ablation of Fibroids and Laparoscopic Myomectomy: Long-Term Follow-up From a Randomized Trial.

Hahn M M Brucker S S Kraemer D D Wallwiener M M Taran F-A FA Wallwiener C W CW Krämer B B

Geburtshilfe und Frauenheilkunde 20150501 5

<b>Aims:</b> 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. <b>Materials and Methods:</b> Our study is a 1 : 1 parallel, randomized, prospective, single-center, longitudinal, ...[more]

PMID: 26097247

Similar Datasets

Project description:BackgroundThe Sonata System is a new minimally invasive, transcervical, uterine-sparing treatment option for fibroids with a mainly intramural location. The device combines intrauterine ultrasonography with radiofrequency ablation. Long-term follow-up data are still lacking.ObjectiveThis study aimed to evaluate long-term outcomes of the Sonata System in terms of surgical reintervention and to identify factors predicting surgical reintervention. Moreover, patient satisfaction, fibroid size reduction, and complication rate were evaluated.Study designWe performed a retrospective single-center cohort study of 53 women who underwent Sonata treatment between December 2011 and April 2019. Medical chart review was conducted to collect data on surgical reintervention and patient, fibroid, and surgery characteristics. The follow-up period lasted from date of initial surgery until April 2020. In addition, women filled out a questionnaire at a single time point (April 2020) containing questions about surgical reintervention and patient satisfaction.Kaplan-Meier analysis was used to determine cumulative reintervention rates and median time without reintervention. Univariate Cox regression analyses were performed to identify factors predicting surgical reintervention.ResultsMedian follow-up period was 36 months (interquartile range, 22-58). Twenty-four women (45.3%) underwent a surgical reintervention, of which most were hysteroscopic myomectomies (45.8%). Surgical reintervention rates as determined by Kaplan-Meier analysis at 1-year and 2-year follow-up were 24.5% and 39.8%, respectively.Eventually, 7 women (13.2%) underwent a hysterectomy after the Sonata treatment. Univariate Cox regression analyses were performed, but did not show a significant association between surgical reintervention and age, preoperative fibroid size, type of ablated fibroid, number of ablated fibroids, and presence of other fibroids that could not be ablated during the Sonata procedure. Median fibroid diameter was 41 mm (interquartile range, 29-50) before and 29 mm (interquartile range, 20-40) after treatment (Z=-5.01; P<.001; 95% confidence interval, -13.0 to 7.0). Thirty-four women (69.4%) were satisfied with the treatment effect, and 42 women (85.7%) would recommend the Sonata treatment to other women. No device-related complications occurred.ConclusionThe Sonata System is a safe and minimally invasive treatment option for women suffering from (partly) intramural fibroids. The findings of this long-term follow-up study support counseling women for treatment with the Sonata System. More prospective studies with long-term follow-up are needed to investigate for which type and size of uterine fibroid the Sonata System is of most value.

Project description:ObjectiveTo examine the quality of life experienced by women with symptomatic uterine fibroids who had been treated with UAE in comparison to myomectomy. We report the four-year follow-up of the FEMME randomised trial. Two-year follow-up data has been previously reported.Study designPremenopausal women who had symptomatic uterine fibroids amenable to myomectomy or uterine artery embolization were recruited from 29 UK hospitals. Women were excluded if they had significant adenomyosis, any malignancy, pelvic inflammatory disease or had had a previous open myomectomy or uterine artery embolization.Participants were randomised to myomectomy or embolization in a 1:1 ratio using a minimisation algorithm. Myomectomy could be open abdominal, laparoscopic or hysteroscopic, according to clinician preference. Embolization of the uterine arteries was performed according to local practice, under fluoroscopic guidance.The primary outcome measure was the Uterine Fibroid Symptom Quality of Life questionnaire, adjusted for baseline score and reported here at four years post-randomisation. Subsequent procedures for fibroids, pregnancy and outcome were amongst secondary outcomes.Trial registration ISRCTN70772394 https://doi.org/10.1186/ISRCTN70772394.Results254 women were randomized, 127 to myomectomy (105 underwent myomectomy) and 127 to uterine artery embolization (98 underwent embolization). At four years, 67 (53%) and 81 (64%) completed UFS-QoL quality of life scores. Mean difference in the UFS-QoL at 4 years was 5.0 points (95% CI -1.4 to 11.5; p = 0.13) in favour of myomectomy. There were 15 pregnancies in the UAE group and 7 in the myomectomy group, with a cumulative pregnancy rate to four years of 15% and 6% respectively (hazard ratio: 0.48; 95% CI 0.18-1.28). The cumulative repeat procedure rate to four years was 24% in the UAE group and 13% in the myomectomy group (hazard ratio: 0.53; 95% CI 0.27-1.05).ConclusionsMyomectomy resulted in greater improvement in quality of life compared with uterine artery embolization, although by four years, this difference was not statistically significant. Missing data may limit the generalisability of this result. The numbers of women becoming pregnant were too small draw a conclusion on the effect of the procedures on fertility.

Dataset Information

Radiofrequency Volumetric Thermal Ablation of Fibroids and Laparoscopic Myomectomy: Long-Term Follow-up From a Randomized Trial.

Publications

Radiofrequency Volumetric Thermal Ablation of Fibroids and Laparoscopic Myomectomy: Long-Term Follow-up From a Randomized Trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets