Trial Information
Reduction of Intraoperative Blood Loss During Laparoscopic Myomectomy by Temporary Clipping of the Uterine Arteries
Inclusion Criteria:
- Patients are eligible for the study when between 18 and 50 years of age,
- diagnosed with either symptomatic or asymptomatic leiomyomata, and with desire to
keep the uterus, and whose leiomyomata had a minimal combined diameter of ≥ 4 cm.
Exclusion Criteria:
- patients with severe accompanying medical problems, or
- with psychiatric illnesses, which jeopardize the participation, or
- undergoing treatment affecting coagulation and/or hematopoiesis, and
- patients with suspected malignancy.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)
Outcome Measure:
Blood loss during laparoscopic myomectomy
Outcome Description:
hemoglobin drop transfusion rate
Outcome Time Frame:
perioperative (preop and postoperative day3)
Safety Issue:
No
Authority:
Germany: Arztekammer Berlin
Study ID:
EA4/07906
NCT ID:
NCT01530802
Start Date:
January 2007
Completion Date:
December 2009
Related Keywords:
- Leiomyoma
- Laparoscopic Myomectomy
- laparoscopic myomectomy, leiomyoma, blood loss, uterine artery
- Leiomyoma
- Myofibroma