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Sponsored by: |
Ullevaal University Hospital |
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Information provided by: | Ullevaal University Hospital |
ClinicalTrials.gov Identifier: | NCT00277680 |
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.
Condition | Intervention |
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Uterine Fibroids |
Procedure: Laparoscopic bilateral occlusion of uterine artery Procedure: Radiological embolization (UFE) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Trial Comparing Laparoscopic Bilateral Occlusion of Uterine Vessels to Uterine Fibroid Embolization for the Treatment of Symptomatic Uterine Fibroids |
Estimated Enrollment: | 60 |
Study Start Date: | December 2000 |
Estimated Study Completion Date: | April 2010 |
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.
Ages Eligible for Study: | 30 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Norway | |
Ullevål University Hospital | |
Oslo, Norway, 0407 |
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 ID Numbers: | MU22200105 |
Study First Received: | January 12, 2006 |
Last Updated: | October 16, 2006 |
ClinicalTrials.gov Identifier: | NCT00277680 |
Health Authority: | Norway: The National Committees for Research Ethics in Norway |
uterine fibroids leiomyoma laparoscopy menorrhagia |
Neoplasms, Connective and Soft Tissue Myofibroma Connective Tissue Diseases Menorrhagia Leiomyoma |
Neoplasms, Muscle Tissue Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue |