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Temporary Clipping of the Uterine Arteries During Laparoscopic Myomectomy

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ClinicalTrials.gov Identifier: NCT01530802
Recruitment Status : Completed
First Posted : February 10, 2012
Last Update Posted : February 10, 2012
Sponsor:
Information provided by:
Charite University, Berlin, Germany

Study Description
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Brief Summary:
The aim is to verify, whether intraoperative temporary clipping of the uterine vessels with vascular clips can reduce blood loss significantly.

Condition or disease Intervention/treatment Phase
Leiomyoma Laparoscopic Myomectomy Procedure: clipping of uterine arteries during laparoscopic myomectomy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: Reduction of Intraoperative Blood Loss During Laparoscopic Myomectomy by Temporary Clipping of the Uterine Arteries
Study Start Date : January 2007
Study Completion Date : December 2009

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Uterine artery clipped
Both uterine arteries are temporarily clipped by Yasargil clips during laparoscopic myomectomy.
 Procedure: 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.
No Intervention: Control group
Conventional laparoscopic myomectomy is performed. (No intervention to temporarily occlude uterine arteries is made)
 Procedure: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Blood loss during laparoscopic myomectomy [ Time Frame: perioperative (preop and postoperative day3) ]
    hemoglobin drop transfusion rate


Secondary Outcome Measures :
  1. Patency of uterine artery after laparoscopic clipping [ Time Frame: perioperative ]
    Doppler results of the uterine arteries


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01530802


Locations
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Germany
Charite University Hospital
Berlin, Germany, 12200
Bernd Holthaus
Damme, Germany
Sponsors and Collaborators
Charite University, Berlin, Germany
More Information
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Responsible Party: Giuseppe Vercellino, Department of Gynecology, Charité Universitätsmedizin, Berlin - Germany
ClinicalTrials.gov Identifier: NCT01530802    
Other Study ID Numbers: EA4/07906
First Posted: February 10, 2012    Key Record Dates
Last Update Posted: February 10, 2012
Last Verified: June 2010
Keywords provided by Charite University, Berlin, Germany:
laparoscopic myomectomy, leiomyoma, blood loss, uterine artery
Additional relevant MeSH terms:
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Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases