Uterine FibroidsNCT00277680
Laparoscopic Occlusion of Uterine Vessels Compared to Uterine Fibroid Embolization for Treatment of Uterine Fibroids
A study testing Laparoscopic bilateral occlusion of uterine artery and Radiological embolization (UFE) in people with Uterine Fibroids, run by Ullevaal University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 30 years and older, women only
- Conditions the study is for
- Uterine Fibroids
- What is being tested?
- Laparoscopic bilateral occlusion of uterine artery and Radiological embolization (UFE)
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- Dec 2000to Apr 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Menorrhagia and/or bulk symptoms associated with uterine fibroids
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Laparoscopic bilateral occlusion of uterine artery, Radiological embolization (UFE)
- Keywords
- uterine fibroids, leiomyoma, laparoscopy, menorrhagia
- Medical subject headings
- Leiomyoma, Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic bilateral occlusion of uterine arteryProcedure or surgery
Radiological embolization (UFE)Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of menstrual bleeding six months after treatment measured by PBAC
Secondary outcomes (8)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2006 (estimated)
- Study startDec 2000
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uterine FibroidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Ullevaal University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Olav Istre, MD,PhD, Study director, Ullevål University Hospital, Dept.of Obstetrics and GynecologyKirsten Hald, MD, Principal investigator, Ullevål University Hospital, Dept of Obstetrics and GynecologyNils-Einar Kløw, MD,PhD, Study chair, Ullevaal University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00277680
- Sponsor's protocol ID
- MU22200105
- Status last verified
- Jan 2006
- First submitted
- 12 Jan 2006
- Last updated
- 6 Jul 2011
- Results posted
- No
Publications
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.
PubMed 17197583
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Comparing Laparoscopic Bilateral Occlusion of Uterine Vessels to Uterine Fibroid Embolization for the Treatment of Symptomatic Uterine Fibroids
- ClinicalTrials.gov ID
- NCT00277680
- Acronym / sponsor ID
- MU22200105
- Conditions
- Uterine Fibroids
- Keywords
- uterine fibroids, leiomyoma, laparoscopy, menorrhagia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants
- Lead sponsor
- Ullevaal University HospitalUniversity, hospital or other
- Study start
- Dec 2000
- Study completion
- Apr 2010
- First posted
- 16 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Menorrhagia and/or bulk symptoms associated with uterine fibroids
Key exclusion criteria (7 listed)
- Malignancy
- Current or planned pregnancy
- Small submucous fibroids suitable for hysteroscopic resection
- Postmenopausal women
- Suspected or known adenomyosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic bilateral occlusion of uterine artery | Procedure or surgery | – |
| Radiological embolization (UFE) | Procedure or surgery | – |
Primary outcome
Reduction of menstrual bleeding six months after treatment measured by PBAC
8 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2011.
- Derived from this study: PubMed 17197583Hald 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olav Istre, MD,PhD study director
Ullevål University Hospital, Dept.of Obstetrics and Gynecology
Kirsten Hald, MD principal investigator
Ullevål University Hospital, Dept of Obstetrics and Gynecology
Nils-Einar Kløw, MD,PhD study chair
Ullevaal University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic bilateral occlusion of uterine artery and Radiological embolization (UFE) in people with Uterine Fibroids, run by Ullevaal University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of menstrual bleeding six months after treatment measured by PBAC. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00277680, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2011.