Temporary Clipping of the Uterine Arteries During Laparoscopic Myomectomy

This study has been completed.
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01530802
First received: November 1, 2010
Last updated: February 9, 2012
Last verified: June 2010

November 1, 2010
February 9, 2012
January 2007
Not Provided
Blood loss during laparoscopic myomectomy [ Time Frame: perioperative (preop and postoperative day3) ] [ Designated as safety issue: No ]
hemoglobin drop transfusion rate
Same as current
Complete list of historical versions of study NCT01530802 on ClinicalTrials.gov Archive Site
Patency of uterine artery after laparoscopic clipping [ Time Frame: perioperative ] [ Designated as safety issue: Yes ]
Doppler results of the uterine arteries
Same as current
Not Provided
Not Provided
 
Temporary Clipping of the Uterine Arteries During Laparoscopic Myomectomy
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
  • Leiomyoma
  • 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.
  • Experimental: Uterine artery clipped
    Both uterine arteries are temporarily clipped by Yasargil clips during laparoscopic myomectomy.
    Intervention: Procedure: clipping of uterine arteries during laparoscopic myomectomy
  • No Intervention: Control group
    Conventional laparoscopic myomectomy is performed. (No intervention to temporarily occlude uterine arteries is made)
    Intervention: Procedure: clipping of uterine arteries during laparoscopic myomectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
166
December 2009
Not Provided

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.
Female
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01530802
EA4/07906
No
Giuseppe Vercellino, Department of Gynecology, Charité Universitätsmedizin, Berlin - Germany
Charite University, Berlin, Germany
Not Provided
Not Provided
Charite University, Berlin, Germany
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP