LeiomyomaNCT01530802
Temporary Clipping of the Uterine Arteries During Laparoscopic Myomectomy
A study testing clipping of uterine arteries during laparoscopic myomectomy in people with Leiomyoma and Laparoscopic Myomectomy, run by Charite University, Berlin, Germany at 2 sites in Germany.
Trial summary
The aim is to verify, whether intraoperative temporary clipping of the uterine vessels with vascular clips can reduce blood loss significantly. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Leiomyoma, Laparoscopic Myomectomy
- What is being tested?
- clipping of uterine arteries during laparoscopic myomectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 2 sitesGermany
- Study dates
- Jan 2007to Dec 2009
- 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients are eligible for the study when between 18 and 50 years of age,
- diagnosed with either symptomatic or asymptomatic leiomyomata, and with desire to keep the uterus, and whose leiomyomata had a minimal combined diameter of ≥ 4 cm.
Who cannot join
- patients with severe accompanying medical problems, or
- with psychiatric illnesses, which jeopardize the participation, or
- undergoing treatment affecting coagulation and/or hematopoiesis, and
- patients with suspected malignancy.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Reduction of Intraoperative Blood Loss During Laparoscopic Myomectomy by Temporary Clipping of the Uterine Arteries
The aim is to verify, whether intraoperative temporary clipping of the uterine vessels with vascular clips can reduce blood loss significantly.
- Conditions
- Leiomyoma, Laparoscopic Myomectomy
- Being tested
- clipping of uterine arteries during laparoscopic myomectomy
- Keywords
- laparoscopic myomectomy, leiomyoma, blood loss, uterine artery
- Medical subject headings
- Leiomyoma, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clipping of uterine arteries during laparoscopic myomectomyProcedure or surgery
For laparoscopy standard instruments were used.For vascular clamping we used titan made YASARGIL vessel clips. The patient is put in a 20° Trendelenburg. The surgeon coagulates a 3-4 cm long segment of peritoneum over the ileopsoas muscle. Along the coagulated segment the peritoneum is opened. The surgeon identifies the ureter at its crossing over the common iliac vessels. After medializing the ureter, the pararectal space is opened and the internal iliac artery is identified and dissected till the origin of the uterine artery. The uterine artery is isolated over a distance of about 2 cm. The vascular clip is placed over the uterine artery. Yasargil Clips are applied exclusively in patients of intervention group. Myomectomy is performed in identical fashion in both groups. At the end of myomectomy the vessel clips are removed. The metroplasty is controlled for hemostasis after reopening of the uterine vessels.
| Study group | Role | What they receive |
|---|---|---|
| Uterine artery clipped | Experimental | Both uterine arteries are temporarily clipped by Yasargil clips during laparoscopic myomectomy. Receives: Procedure: clipping of uterine arteries during laparoscopic myomectomy |
| Control group | No intervention | Conventional laparoscopic myomectomy is performed. (No intervention to temporarily occlude uterine arteries is made) Receives: Procedure: clipping of uterine arteries during laparoscopic myomectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss during laparoscopic myomectomy
hemoglobin drop transfusion rate
Measured: perioperative (preop and postoperative day3)
Secondary outcomes (1)
Patency of uterine artery after laparoscopic clipping
Doppler results of the uterine arteries
Measured: perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2012 (estimated)
- Study startJan 2007
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeiomyomaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01530802
- Sponsor's protocol ID
- EA4/07906
- Status last verified
- Jun 2010
- First submitted
- 1 Nov 2010
- Last updated
- 10 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Intraoperative Blood Loss During Laparoscopic Myomectomy by Temporary Clipping of the Uterine Arteries
- ClinicalTrials.gov ID
- NCT01530802
- Acronym / sponsor ID
- EA4/07906
- Conditions
- Leiomyoma, Laparoscopic Myomectomy
- Keywords
- laparoscopic myomectomy, leiomyoma, blood loss, uterine artery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Jan 2007
- Study completion
- Dec 2009
- First posted
- 10 Feb 2012 (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.
The aim is to verify, whether intraoperative temporary clipping of the uterine vessels with vascular clips can reduce blood loss significantly.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Uterine artery clipped | Experimental | Procedure: clipping of uterine arteries during laparoscopic myomectomyBoth uterine arteries are temporarily clipped by Yasargil clips during laparoscopic myomectomy. |
| Control group | No intervention | Procedure: clipping of uterine arteries during laparoscopic myomectomyConventional laparoscopic myomectomy is performed. (No intervention to temporarily occlude uterine arteries is made) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients are eligible for the study when between 18 and 50 years of age,
- diagnosed with either symptomatic or asymptomatic leiomyomata, and with desire to keep the uterus, and whose leiomyomata had a minimal combined diameter of ≥ 4 cm.
Key exclusion criteria (4 listed)
- patients with severe accompanying medical problems, or
- with psychiatric illnesses, which jeopardize the participation, or
- undergoing treatment affecting coagulation and/or hematopoiesis, and
- patients with suspected malignancy.
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 |
|---|---|---|
| clipping of uterine arteries during laparoscopic myomectomyFor laparoscopy standard instruments were used.For vascular clamping we used titan made YASARGIL vessel clips. The patient is put in a 20° Trendelenburg. The surgeon coagulates a 3-4 cm long segment of peritoneum over the ileopsoas muscle. Along the coagulated segment the peritoneum is opened. The surgeon identifies the ureter at its crossing over the common iliac vessels. After medializing the ureter, the pararectal space is opened and the internal iliac artery is identified and dissected till the origin of the uterine artery. The uterine artery is isolated over a distance of about 2 cm. The vascular clip is placed over the uterine artery. Yasargil Clips are applied exclusively in patients of intervention group. Myomectomy is performed in identical fashion in both groups. At the end of myomectomy the vessel clips are removed. The metroplasty is controlled for hemostasis after reopening of the uterine vessels. | Procedure or surgery | Control group, Uterine artery clipped |
Primary outcome
Blood loss during laparoscopic myomectomy
Time frame: perioperative (preop and postoperative day3)
hemoglobin drop transfusion rate
1 secondary outcome
Patency of uterine artery after laparoscopic clipping
Time frame: perioperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clipping of uterine arteries during laparoscopic myomectomy in people with Leiomyoma and Laparoscopic Myomectomy, run by Charite University, Berlin, Germany at 2 sites in Germany.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 10 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Blood loss during laparoscopic myomectomy (time frame: perioperative (preop and postoperative day3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2012.