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

Uterine Fibroids Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00277680
• Other study ID #: MU22200105
• Status: Active, not recruiting
• Phase: N/A
• First received: January 12, 2006
• Last updated: July 3, 2011
• Start date: December 2000
• Est. completion date: April 2010

Study information

• Verified date: January 2006
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroids

Intervention

Procedure:
• Laparoscopic bilateral occlusion of uterine artery

• Radiological embolization (UFE)

Locations

Country	Name	City	State
Norway	Ullevål University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Ullevaal University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of menstrual bleeding six months after treatment measured by PBAC
Secondary	Patient assessment of symptom reduction including menorrhagia and bulk symptoms
Secondary	postoperative pain
Secondary	recovering time
Secondary	complications
Secondary	failures
Secondary	recurrence
Secondary	secondary interventions
Secondary	Reduction in fibroids and uterus size measured by ultrasonography and MRI