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Clinical Trials/NCT01530802
NCT01530802CompletedNot Applicable

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

Charite University, Berlin, Germany3 sites in 1 country166 target enrollmentStarted: January 2007Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
166
Locations
3
Primary Endpoint
Blood loss during laparoscopic myomectomy
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

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)

Investigators

Sponsor Class
Other

Study Sites (3)

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