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Three-year outcome of the Halt trial: a prospective analysis of radiofrequency volumetric thermal ablation of myomas.

Identifieur interne : 004266 ( PubMed/Checkpoint ); précédent : 004265; suivant : 004267

Three-year outcome of the Halt trial: a prospective analysis of radiofrequency volumetric thermal ablation of myomas.

Auteurs : Jay M. Berman [États-Unis] ; Richard S. Guido [États-Unis] ; José Gerardo Garza Leal [Mexique] ; Rodolfo Robles Pemueller [Guatemala] ; Fredrick S. Whaley [États-Unis] ; Scott G. Chudnoff [États-Unis]

Source :

RBID : pubmed:24613404

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English descriptors

Abstract

To analyze the clinical success of radiofrequency volumetric thermal ablation (RFVTA) at 3-year follow-up in terms of subject responses to validated questionnaires and surgical repeat intervention to treat myomas.

DOI: 10.1016/j.jmig.2014.02.015
PubMed: 24613404


Affiliations:


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pubmed:24613404

Le document en format XML

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<div type="abstract" xml:lang="en">To analyze the clinical success of radiofrequency volumetric thermal ablation (RFVTA) at 3-year follow-up in terms of subject responses to validated questionnaires and surgical repeat intervention to treat myomas.</div>
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<ArticleTitle>Three-year outcome of the Halt trial: a prospective analysis of radiofrequency volumetric thermal ablation of myomas.</ArticleTitle>
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<AbstractText Label="STUDY OBJECTIVE" NlmCategory="OBJECTIVE">To analyze the clinical success of radiofrequency volumetric thermal ablation (RFVTA) at 3-year follow-up in terms of subject responses to validated questionnaires and surgical repeat intervention to treat myomas.</AbstractText>
<AbstractText Label="DESIGN" NlmCategory="METHODS">Prospective follow-up of patients for 36 months after treatment in a multicenter international trial of outpatient, laparoscopic ultrasound-guided RFVTA of symptomatic uterine myomas (Canadian Task Force classification II-1).</AbstractText>
<AbstractText Label="SETTING" NlmCategory="METHODS">University hospitals and private surgical centers.</AbstractText>
<AbstractText Label="PATIENTS" NlmCategory="METHODS">One hundred thirty-five premenopausal women (mean [SD] age, 42.5 [4.6] years; body mass index, 30.5 [6.1]) with symptomatic uterine myomas and objectively confirmed heavy menstrual bleeding (≥ 160 to ≤ 500 mL).</AbstractText>
<AbstractText Label="INTERVENTIONS" NlmCategory="METHODS">Laparoscopic ultrasound-guided RFVTA.</AbstractText>
<AbstractText Label="MEASUREMENTS AND MAIN RESULTS" NlmCategory="RESULTS">One hundred four participants were followed prospectively for 36 months after treatment of myomas via RFVTA. For 104 evaluable participants with 36-month data, change in mean (SD) symptom severity from baseline (60.2 [18.8]) to 36 months was -32.6 (95% confidence interval, -37.5 to -27.8; p < .001). Health-related quality of life also was improved, from the baseline value of 39.2 (19.2) to 38.6 (95% confidence interval, 33.3 to 43.9; p < .001) at 36 months. Patient-reported Uterine Fibroid Symptom and Health-Related Quality of Life questionnaire subscores demonstrated statistically significant improvement from baseline to 36 months in all categories (Concern, Activities, Energy/Mood, Control, Self-consciousness, and Sexual Function) (p < .001). For the 104 participants with 36-month data, mean state of health scores (EuroQOL-5D Health State Index) improved from a baseline value of 71.0 (19.3) to 86.2 (11.7) at 36 months. The cumulative repeat intervention rate of 11% (14 of 135 participants) at 36 months was well below the possible 25% maximum expected at the beginning of the trial.</AbstractText>
<AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">RFVTA of uterine myomas resulted in sustained relief from myoma symptoms and continued improvement in health-related quality of life through 36 months after ablation. The low repeat intervention data through 36 months is a positive outcome for patient well-being.</AbstractText>
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<name sortKey="Pemueller, Rodolfo Robles" sort="Pemueller, Rodolfo Robles" uniqKey="Pemueller R" first="Rodolfo Robles" last="Pemueller">Rodolfo Robles Pemueller</name>
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