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Clinical Trials/NCT01530802
NCT01530802
Completed
Not Applicable

Reduction of Intraoperative Blood Loss During Laparoscopic Myomectomy by Temporary Clipping of the Uterine Arteries

Charite University, Berlin, Germany2 sites in 1 country166 target enrollmentJanuary 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Leiomyoma
Sponsor
Charite University, Berlin, Germany
Enrollment
166
Locations
2
Primary Endpoint
Blood loss during laparoscopic myomectomy
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

The aim is to verify, whether intraoperative temporary clipping of the uterine vessels with vascular clips can reduce blood loss significantly.

Registry
clinicaltrials.gov
Start Date
January 2007
End Date
December 2009
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Blood loss during laparoscopic myomectomy

Time Frame: perioperative (preop and postoperative day3)

hemoglobin drop transfusion rate

Secondary Outcomes

  • Patency of uterine artery after laparoscopic clipping(perioperative)

Study Sites (2)

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