COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00277680
Recruitment Status : Unknown
Verified January 2006 by Oslo University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : January 16, 2006
Last Update Posted : July 6, 2011
Information provided by:
Oslo University Hospital

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.

Condition or disease Intervention/treatment Phase
Uterine Fibroids Procedure: Laparoscopic bilateral occlusion of uterine artery Procedure: Radiological embolization (UFE) Not Applicable

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial Comparing Laparoscopic Bilateral Occlusion of Uterine Vessels to Uterine Fibroid Embolization for the Treatment of Symptomatic Uterine Fibroids
Study Start Date : December 2000
Study Completion Date : April 2010

Primary Outcome Measures :
  1. Reduction of menstrual bleeding six months after treatment measured by PBAC

Secondary Outcome Measures :
  1. Patient assessment of symptom reduction including menorrhagia and bulk symptoms
  2. postoperative pain
  3. recovering time
  4. complications
  5. failures
  6. recurrence
  7. secondary interventions
  8. Reduction in fibroids and uterus size measured by ultrasonography and MRI

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00277680

Layout table for location information
Ullevål University Hospital
Oslo, Norway, 0407
Sponsors and Collaborators
Ullevaal University Hospital
Layout table for investigator information
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
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00277680    
Other Study ID Numbers: MU22200105
First Posted: January 16, 2006    Key Record Dates
Last Update Posted: July 6, 2011
Last Verified: January 2006
Keywords provided by Oslo University Hospital:
uterine fibroids
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Connective Tissue Diseases