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
  Purpose

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


Condition Intervention
Leiomyoma
Laparoscopic Myomectomy
Procedure: clipping of uterine arteries during laparoscopic myomectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Reduction of Intraoperative Blood Loss During Laparoscopic Myomectomy by Temporary Clipping of the Uterine Arteries

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Blood loss during laparoscopic myomectomy [ Time Frame: perioperative (preop and postoperative day3) ] [ Designated as safety issue: No ]
    hemoglobin drop transfusion rate


Secondary Outcome Measures:
  • Patency of uterine artery after laparoscopic clipping [ Time Frame: perioperative ] [ Designated as safety issue: Yes ]
    Doppler results of the uterine arteries


Enrollment: 166
Study Start Date: January 2007
Estimated Study Completion Date: December 2009
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01530802

Locations
Germany
Charite University Hospital
Berlin, Germany, 12200
Bernd Holthaus
Damme, Germany
Sponsors and Collaborators
Charite University, Berlin, Germany
  More Information

No publications provided

Responsible Party: Giuseppe Vercellino, Department of Gynecology, Charité Universitätsmedizin, Berlin - Germany
ClinicalTrials.gov Identifier: NCT01530802     History of Changes
Other Study ID Numbers: EA4/07906
Study First Received: November 1, 2010
Last Updated: February 9, 2012
Health Authority: Germany: Arztekammer Berlin

Keywords provided by Charite University, Berlin, Germany:
laparoscopic myomectomy, leiomyoma, blood loss, uterine artery

Additional relevant MeSH terms:
Leiomyoma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on September 30, 2014