The removal of intrauterine leiomyomas through transvaginal ultrasound-guided radiofrequency ablation is a clinical- and cost-effective alternative for laparoscopic hysterectomy and tomic myomectomy.
ID
Bron
Verkorte titel
Aandoening
intrauterine leiomyomas, intrauterine fibroids, heavy menstrual bleeding
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Time to return to work in days
Achtergrond van het onderzoek
Uterine leiomyomas are the most common neoplasms affecting adult women with a prevalence rate of ~20-25% which often require intervention. Hysterectomy and tomic myomectomy are common treatment in the Netherlands which are associated with morbidity and productivity loss. An alternative less invasive therapy is intrauterine ultrasound (IUUS)-guided transvaginal radiofrequency (RF) ablation. Although good results are accomplished for this therapy in single-arm trials, comparative and cost-effectiveness studies needed for broad implementation are lacking. Therefore, the present study is being undertaken to compare disease-specific quality of life and the cost-effectiveness of IUUS-RF ablation of leiomyomas with the Sonata system compared to usual care (total laparoscopic hysterectomy, and tomic myomectomy) in a prospective, single center, cohort study.
Doel van het onderzoek
The removal of intrauterine leiomyomas through transvaginal ultrasound-guided radiofrequency ablation is a clinical- and cost-effective alternative for laparoscopic hysterectomy and tomic myomectomy.
Onderzoeksopzet
Baseline, 6, 12 and 18 months after intervention
Onderzoeksproduct en/of interventie
Removal of intrauterine leiomyomas through transvaginal ultrasound-guided radiofrequency ablation (Sonata system)
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Have selected Sonata, tomic myomectomy, laparoscopic hysterectomy for the treatment of leiomyomas
2. Presence of at least one submucous myoma (type 2) or transmural fibroid (type 2-5)
3. ≥ 25 years of age at the time of enrollment
4. American Society of Anesthesiologist class 1 or 2
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Clotting disorders
2. Inability to understand Dutch or English
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8248 |
| Ander register | Commissie Lokale Uitvoerbaarheid Máxima Medical Center : L19.135 |