This trial is active, not recruiting.

Condition uterine fibroids
Treatments laparoscopic bilateral occlusion of uterine artery, radiological embolization (ufe)
Sponsor Ullevaal University Hospital
Start date December 2000
End date April 2010
Trial size 60 participants
Trial identifier NCT00277680, MU22200105


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Reduction of menstrual bleeding six months after treatment measured by PBAC
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Secondary Outcomes

Patient assessment of symptom reduction including menorrhagia and bulk symptoms
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postoperative pain
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recovering time
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secondary interventions
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Reduction in fibroids and uterus size measured by ultrasonography and MRI
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Eligibility Criteria

Female participants at least 30 years old.

Inclusion Criteria: - Menorrhagia and/or bulk symptoms associated with uterine fibroids Exclusion Criteria: - 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

Additional Information

Official title A Randomized Trial Comparing Laparoscopic Bilateral Occlusion of Uterine Vessels to Uterine Fibroid Embolization for the Treatment of Symptomatic Uterine Fibroids
Principal investigator Kirsten Hald, MD
Description Uterine fibroid embolization (UFE)has become an alternative to hysterectomy for women with symptoms of uterine fibroids.Follow up studies of this new method have reported relief of menstrual bleeding by 85-90 % of the patients six to twelve months after treatment.Other studies have suggested laparoscopic bilateral occlusion of uterine arteries as an equal effective alternative, but to our knowledge there is no randomized studies published. Patients recruitment : Women with symptoms of uterine fibroids referred to the clinic,who express a desire to avoid hysterectomy. Study hypothesis: Laparoscopic occlusion of uterine vessels and UFE have equal effect on bleeding symptoms. Gynecological examination, ultrasonography and magnetic resonance imaging (MRI) are performed preoperatively and after 1,3 and 6 months. Clinical follow up is planned after 1,3,6,12,24,36 and 60 months.A validated bleeding chard, Pictorial Blood Assessment Chart(PBAC)is filled in by the participants during the last menstruation period before treatment and before each control. A standardized questionnaire to assess the bleeding amount,pressure symptoms, pain, adverse events, other complains and patients satisfaction is also used.
Trial information was received from ClinicalTrials.gov and was last updated in July 2011.
Information provided to ClinicalTrials.gov by Oslo University Hospital.