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

July 3, 2011 updated by: Ullevaal University Hospital

A Randomized Trial Comparing Laparoscopic Bilateral Occlusion of Uterine Vessels to Uterine Fibroid Embolization for the Treatment of Symptomatic Uterine Fibroids

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0407
        • Ullevål University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Reduction of menstrual bleeding six months after treatment measured by PBAC

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2000

Study Completion

April 1, 2010

Study Registration Dates

First Submitted

January 12, 2006

First Submitted That Met QC Criteria

January 13, 2006

First Posted (Estimate)

January 16, 2006

Study Record Updates

Last Update Posted (Estimate)

July 6, 2011

Last Update Submitted That Met QC Criteria

July 3, 2011

Last Verified

January 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MU22200105

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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