Clinical trial NCT00277680: Laparoscopic Occlusion of Uterine Vessels Compared to Uterine Fibroid Embolization for Treatment of Uterine Fibroids
Official title: A Randomized Trial Comparing Laparoscopic Bilateral Occlusion of Uterine Vessels to Uterine Fibroid Embolization for the Treatment of Symptomatic Uterine Fibroids
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Uterine Fibroids
Keywords: uterine fibroids
leiomyoma
laparoscopy
menorrhagia
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2006-01-16
Enrollment: 60
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Reduction of menstrual bleeding six months after treatment measured by PBAC
Secondary outcomes:
measure: Patient assessment of symptom reduction including menorrhagia and bulk symptoms
measure: postoperative pain
measure: recovering time
measure: complications
measure: failures
measure: recurrence
measure: secondary interventions
measure: Reduction in fibroids and uterus size measured by ultrasonography and MRI
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Ullevål University Hospital
Study officials:
affiliation: Ullevål University Hospital, Dept.of Obstetrics and Gynecology
name: Olav Istre, MD,PhD
role: STUDY_DIRECTOR
affiliation: Ullevål University Hospital, Dept of Obstetrics and Gynecology
name: Kirsten Hald, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ullevaal University Hospital
name: Nils-Einar Kløw, MD,PhD
role: STUDY_CHAIR
References:
citation: 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.