Temporary Clipping of the Uterine Arteries During Laparoscopic Myomectomy
NCT ID: NCT01530802
Last Updated: 2012-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
166 participants
INTERVENTIONAL
2007-01-31
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SINGLE
Study Groups
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Uterine artery clipped
Both uterine arteries are temporarily clipped by Yasargil clips during laparoscopic myomectomy.
clipping of uterine arteries during laparoscopic myomectomy
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.
Control group
Conventional laparoscopic myomectomy is performed. (No intervention to temporarily occlude uterine arteries is made)
clipping of uterine arteries during laparoscopic myomectomy
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.
Interventions
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clipping of uterine arteries during laparoscopic myomectomy
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* with psychiatric illnesses, which jeopardize the participation, or
* undergoing treatment affecting coagulation and/or hematopoiesis, and
* patients with suspected malignancy.
18 Years
50 Years
FEMALE
No
Sponsors
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Charite University, Berlin, Germany
OTHER
Responsible Party
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Department of Gynecology, Charité Universitätsmedizin, Berlin - Germany
Locations
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Charite University Hospital
Berlin, , Germany
Bernd Holthaus
Damme, , Germany
Countries
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Other Identifiers
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EA4/07906
Identifier Type: -
Identifier Source: org_study_id
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