The purpose of this study is to compare the outcomes of two uterine-conserving treatment alternatives for symptomatic uterine fibroids: laparoscopic myomectomy (LM) and global fibroid ablation (GFA) using the Halt System. Laparoscopic ultrasound (LUS) is a standard step prior to the GFA procedure but has not been a standard step prior to LM. Incorporating laparoscopic ultrasound as a first step prior to both treatments allows the surgeon to have equal access to valuable imaging information and to plan treatment accordingly. By randomizing the subject immediately after laparoscopic ultrasound, selection bias toward one treatment or the other following the LUS is eliminated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
51
Tubingen University Hospital
Tübingen, Germany
Compare the mean time of hospitalization following laparoscopic treatment of fibroids by myomectomy or GFA
Capture and compare hospitalization time expressed as the number of hours from induction of anesthesia to discharge from hospital.
Time frame: From admission to the duration of hospital stay, an expected average of 3 days
Compare and contrast post-treatment readmission and reintervention rate
Compare incidence of post discharge readmission within 1 month of procedure and rate of reintervention for fibroid-related symptoms up to 60 months post procedure
Time frame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months post treatment
Compare and Contrast peri and post procedural safety including procedural blood loss and complications
Compare intraoperative blood loss and rate of procedural-related complications up to 60 months post treatment
Time frame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months post-treatment
Compare and contrast recovery rate
Compare how many days it takes to return-to-work and to normal activities of daily living.
Time frame: Discharge from hospital up to an average of 5 weeks post treatment
Compare and Contrast post-treatment changes in fibroid symptom severity.
Compare Baseline fibroid related symptoms to 3, 6, 12, 24, 36, 48 and 60 months post treatment
Time frame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months post-treatment
Compare and contrast post-treatment patient satisfaction
Compare the overall subject treatment outcome and satisfaction evaluation
Time frame: 3, 6, 12, 24, 36, 48, and 60 months post-treatment
Compare and Contrast post-treatment changes in menstrual status.
Compare Baseline menstrual impact to 3, 6, 12, 24, 36, 48 and 60 months post treatment.
Time frame: Baseline, 3, 6 ,12, 24, 36, 48, and 60 months post treatment
Compare and Contrast post-treatment changes concerning health-related quality-of-life.
Compare Baseline general health outcome to 3, 6, 12, 24, 36, 48 and 60 months post treatment.
Time frame: Baseline, 3, 6 ,12, 24, 36, 48, and 60 months post treatment
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