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Laparoscopic Occlusion of Uterine Vessels Compared to Uterine Fibroid Embolization for Treatment of Uterine Fibroids

NCT00277680 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2011-07-06

No results posted yet for this study

Summary

Women with symptomatic uterine fibroids are treated either by Uterine Fibroid Embolization (UFE) or laparoscopic occlusion. The study hypothesis is that laparoscopic occlusion of uterine vessels and UFE have equal effect on bleeding symptoms. Menstrual bleeding reduction six months after treatment is the main endpoint. Secondary endpoints include participants assessment of symptom relief, and volume reduction of fibroids measured by MRI. We will also investigate possible differences in postoperative course, symptom reduction, complication, and recurrence. Patients are controlled with regular intervals up to five years after treatment.

Conditions

  • Uterine Fibroids

Interventions

PROCEDURE

Laparoscopic bilateral occlusion of uterine artery

PROCEDURE

Radiological embolization (UFE)

Sponsors & Collaborators

  • Ullevaal University Hospital

    lead OTHER

Principal Investigators

  • Olav Istre, MD,PhD · Ullevål University Hospital, Dept.of Obstetrics and Gynecology

  • Kirsten Hald, MD · Ullevål University Hospital, Dept of Obstetrics and Gynecology

  • Nils-Einar Kløw, MD,PhD · Ullevaal University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-12-31
Completion
2010-04-30

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00277680 on ClinicalTrials.gov