Laparoscopic Uterine Sparing Techniques Outcomes and Reinterventions (LUSTOR)
|ClinicalTrials.gov Identifier: NCT01750008|
Recruitment Status : Completed
First Posted : December 17, 2012
Last Update Posted : June 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Uterine Fibroids Myomas||Procedure: Global Fibroid Ablation Procedure: Myomectomy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Study compares two laparoscopic interventions for the treatment of symptomatic uterine fibroids.|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The LUSTOR (Laparoscopic Uterine Sparing Techniques Outcomes and Reinterventions)Trial|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||June 2018|
Global Fibroid Ablation
Global Fibroid Ablation
Procedure: Global Fibroid Ablation
Myomectomy via laparoscopy
- Compare the mean time of hospitalization following laparoscopic treatment of fibroids by myomectomy or GFA [ Time Frame: From admission to the duration of hospital stay, an expected average of 3 days ]Capture and compare hospitalization time expressed as the number of hours from induction of anesthesia to discharge from hospital.
- Compare and contrast post-treatment readmission and reintervention rate [ Time Frame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months post treatment ]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
- Compare and Contrast peri and post procedural safety including procedural blood loss and complications [ Time Frame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months post-treatment ]Compare intraoperative blood loss and rate of procedural-related complications up to 60 months post treatment
- Compare and contrast recovery rate [ Time Frame: Discharge from hospital up to an average of 5 weeks post treatment ]Compare how many days it takes to return-to-work and to normal activities of daily living.
- Compare and Contrast post-treatment changes in fibroid symptom severity. [ Time Frame: Baseline and 3, 6, 12, 24, 36, 48, and 60 months post-treatment ]Compare Baseline fibroid related symptoms to 3, 6, 12, 24, 36, 48 and 60 months post treatment
- Compare and contrast post-treatment patient satisfaction [ Time Frame: 3, 6, 12, 24, 36, 48, and 60 months post-treatment ]Compare the overall subject treatment outcome and satisfaction evaluation
- Compare and Contrast post-treatment changes in menstrual status. [ Time Frame: Baseline, 3, 6 ,12, 24, 36, 48, and 60 months post treatment ]Compare Baseline menstrual impact to 3, 6, 12, 24, 36, 48 and 60 months post treatment.
- Compare and Contrast post-treatment changes concerning health-related quality-of-life. [ Time Frame: Baseline, 3, 6 ,12, 24, 36, 48, and 60 months post treatment ]Compare Baseline general health outcome to 3, 6, 12, 24, 36, 48 and 60 months post treatment.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01750008
|Tubingen University Hospital|
|Tubingen, Germany, 72074|
|Principal Investigator:||Sara Brucker, MD||University of Tubingen|