Laparoscopic Uterine Sparing Techniques Outcomes and Reinterventions (LUSTOR)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01750008|
Recruitment Status : Active, not recruiting
First Posted : December 17, 2012
Last Update Posted : July 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Uterine Fibroids Myomas||Procedure: Global Fibroid Ablation Procedure: Myomectomy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 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|
|Estimated Study Completion Date :||September 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|