No registrations found.
ID
Source
Brief title
Health condition
intrauterine leiomyomas, intrauterine fibroids, heavy menstrual bleeding
Sponsors and support
Intervention
Outcome measures
Primary outcome
Time to return to work in days
Secondary outcome
Uterine fibroid symptom and health-related quality of life, Reintervention rate, Complications,Costs, Satisfaction and recommendation to friend
Background summary
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.
Study objective
The removal of intrauterine leiomyomas through transvaginal ultrasound-guided radiofrequency ablation is a clinical- and cost-effective alternative for laparoscopic hysterectomy and tomic myomectomy.
Study design
Baseline, 6, 12 and 18 months after intervention
Intervention
Removal of intrauterine leiomyomas through transvaginal ultrasound-guided radiofrequency ablation (Sonata system)
Inclusion criteria
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
Exclusion criteria
1. Clotting disorders
2. Inability to understand Dutch or English
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8248 |
| Other | Commissie Lokale Uitvoerbaarheid Máxima Medical Center : L19.135 |