Laparoscopic radiofrequency fibroid ablation: Phase ii and phase iii results

Donald I. Galen, Rodolfo Robles Pemueller, José Gerardo Garza Leal, Karen R. Abbott, Janice L. Falls, James Macer

Research output: Contribution to journalArticle

12 Scopus citations

Abstract

Background and Objectives: To review phase II and phase III treatments of symptomatic uterine fibroids (myomas) using laparoscopic radiofrequency volumetric thermal ablation (RFVTA). Methods: We performed a retrospective, multicenter clinical analysis of 206 consecutive cases of ultrasoundguided laparoscopic RFVTA of symptomatic myomas conducted on an outpatient basis under two phase II studies at 2 sites (n = 69) and one phase III study at 11 sites (n = 137). Descriptive and exploratory, general trend, and matched-pair analyses were applied. Results: From baseline to 12 months in the phase II study, the mean transformed symptom severity scores improved from 53.9 to 8.8 (P<.001) (n = 57), health-related quality-of-life scores improved from 48.5 to 92.0 (P <.001) (n = 57), and mean uterine volume decreased from 204.4 cm3 to 151.4 cm3 (P =.008) (n = 58). Patients missed a median of 4 days of work (range, 2-10 days). The rate of possible device-related adverse events was 1.4% (1 of 69). In the phase III study, approximately 98% of patients were assessed at 12 months, and their transformed symptom severity scores, health-related qualityof- life scores, mean decrease in uterine volume, and mean menstrual bleeding reduction were also significant. Patients in phase III missed a median of 5 days of work (range, 1-29 days). The rate of periprocedural devicerelated adverse events was 3.5% (5 of 137). Despite the enrollment requirement for patients in both phases to have completed childbearing, 4 pregnancies occurred within the first year after treatment. Conclusions: RFVTA does not require any uterine incisions and provides a uterine-sparing procedure with rapid recovery, significant reduction in uterine size, significant reduction or elimination of myoma symptoms, and significant improvement in quality of life.

Original languageEnglish (US)
Pages (from-to)182-190
Number of pages9
JournalJournal of the Society of Laparoendoscopic Surgeons
Volume18
Issue number2
DOIs
Publication statusPublished - Jan 1 2014

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Keywords

  • Fibroid
  • Laparoscopic ultrasound
  • Laparoscopy
  • Myoma
  • Radiofrequency ablation

ASJC Scopus subject areas

  • Surgery

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