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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2006 by Oslo University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00277680
First received: January 12, 2006
Last updated: July 3, 2011
Last verified: January 2006
  Purpose

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
Uterine Fibroids
Procedure: Laparoscopic bilateral occlusion of uterine artery
Procedure: Radiological embolization (UFE)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by Oslo University Hospital:

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

Secondary Outcome Measures:
  • Patient assessment of symptom reduction including menorrhagia and bulk symptoms
  • postoperative pain
  • recovering time
  • complications
  • failures
  • recurrence
  • secondary interventions
  • Reduction in fibroids and uterus size measured by ultrasonography and MRI

Estimated Enrollment: 60
Study Start Date: December 2000
Estimated Study Completion Date: April 2010
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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00277680

Locations
Norway
Ullevål University Hospital
Oslo, Norway, 0407
Sponsors and Collaborators
Ullevaal University Hospital
Investigators
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
  More Information

No publications provided by Oslo University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00277680     History of Changes
Other Study ID Numbers: MU22200105
Study First Received: January 12, 2006
Last Updated: July 3, 2011
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Oslo University Hospital:
uterine fibroids
leiomyoma
laparoscopy
menorrhagia

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Connective Tissue Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Neoplasms, Connective Tissue
Neoplasms, Muscle Tissue

ClinicalTrials.gov processed this record on October 29, 2014