TY - JOUR
T1 - Laparoscopic radiofrequency fibroid ablation
T2 - Phase ii and phase iii results
AU - Galen, Donald I.
AU - Pemueller, Rodolfo Robles
AU - Leal, José Gerardo Garza
AU - Abbott, Karen R.
AU - Falls, Janice L.
AU - Macer, James
PY - 2014
Y1 - 2014
N2 - 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.
AB - 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.
KW - Fibroid
KW - Laparoscopic ultrasound
KW - Laparoscopy
KW - Myoma
KW - Radiofrequency ablation
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U2 - 10.4293/108680813X13693422518353
DO - 10.4293/108680813X13693422518353
M3 - Article
C2 - 24960480
AN - SCOPUS:84902951074
SN - 1086-8089
VL - 18
SP - 182
EP - 190
JO - Journal of the Society of Laparoendoscopic Surgeons
JF - Journal of the Society of Laparoendoscopic Surgeons
IS - 2
ER -