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

NCT ID: NCT00277680

Last Updated: 2011-07-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-12-31
• Study Completion Date: 2010-04-30

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.

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.

Conditions

Uterine Fibroids

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Laparoscopic bilateral occlusion of uterine artery

Intervention Type: PROCEDURE

Radiological embolization (UFE)

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ullevaal University Hospital

OTHER

Sponsor Role: lead

Principal Investigators

Olav Istre, MD,PhD

Role: STUDY_DIRECTOR

Ullevål University Hospital, Dept.of Obstetrics and Gynecology

Kirsten Hald, MD

Role: PRINCIPAL_INVESTIGATOR

Ullevål University Hospital, Dept of Obstetrics and Gynecology

Nils-Einar Kløw, MD,PhD

Role: STUDY_CHAIR

Ullevaal University Hospital

Locations

Ullevål University Hospital

Oslo, Oslo County, Norway

Countries

Norway

References

Hald K, Klow NE, Qvigstad E, Istre O. Laparoscopic occlusion compared with embolization of uterine vessels: a randomized controlled trial. Obstet Gynecol. 2007 Jan;109(1):20-7. doi: 10.1097/01.AOG.0000249602.39339.31.

Reference Type: DERIVED

PMID: 17197583 (View on PubMed)

Other Identifiers

MU22200105

Identifier Type: -

Identifier Source: org_study_id