Laparoscopic Occlusion of Uterine Vessels Compared to Uterine Fibroid Embolization for Treatment of Uterine Fibroids
A Randomized Trial Comparing Laparoscopic Bilateral Occlusion of Uterine Vessels to Uterine Fibroid Embolization for the Treatment of Symptomatic Uterine Fibroids
1 other identifier
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2000
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2000
CompletedFirst Submitted
Initial submission to the registry
January 12, 2006
CompletedFirst Posted
Study publicly available on registry
January 16, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedJuly 6, 2011
January 1, 2006
January 12, 2006
July 3, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction of menstrual bleeding six months after treatment measured by PBAC
Secondary Outcomes (8)
Patient assessment of symptom reduction including menorrhagia and bulk symptoms
postoperative pain
recovering time
complications
failures
- +3 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Menorrhagia and/or bulk symptoms associated with uterine fibroids
You may not qualify if:
- Malignancy
- Current or planned pregnancy
- Small submucous fibroids suitable for hysteroscopic resection
- Postmenopausal women
- Suspected or known adenomyosis
- Uterus size exceeding the umbilical level
- Contraindications against laparoscopic surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ullevål University Hospital
Oslo, Oslo County, 0407, Norway
Related Publications (1)
Hald K, Klow NE, Qvigstad E, Istre O. Laparoscopic occlusion compared with embolization of uterine vessels: a randomized controlled trial. Obstet Gynecol. 2007 Jan;109(1):20-7. doi: 10.1097/01.AOG.0000249602.39339.31.
PMID: 17197583DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Olav Istre, MD,PhD
Ullevål University Hospital, Dept.of Obstetrics and Gynecology
- PRINCIPAL INVESTIGATOR
Kirsten Hald, MD
Ullevål University Hospital, Dept of Obstetrics and Gynecology
- STUDY CHAIR
Nils-Einar Kløw, MD,PhD
Ullevaal University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 12, 2006
First Posted
January 16, 2006
Study Start
December 1, 2000
Study Completion
April 1, 2010
Last Updated
July 6, 2011
Record last verified: 2006-01