Temporary Clipping of the Uterine Arteries During Laparoscopic Myomectomy

Leiomyoma Clinical Trial

Official title:

Reduction of Intraoperative Blood Loss During Laparoscopic Myomectomy by Temporary Clipping of the Uterine Arteries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01530802
• Other study ID #: EA4/07906
• Status: Completed
• Phase: N/A
• First received: November 1, 2010
• Last updated: February 9, 2012
• Start date: January 2007
• Est. completion date: December 2009

Study information

• Verified date: June 2010
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Arztekammer Berlin
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Laparoscopic Myomectomy
• Leiomyoma

Intervention

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.

Locations

Country	Name	City	State
Germany	Charite University Hospital	Berlin
Germany	Bernd Holthaus	Damme

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood loss during laparoscopic myomectomy	hemoglobin drop transfusion rate	perioperative (preop and postoperative day3)	No
Secondary	Patency of uterine artery after laparoscopic clipping	Doppler results of the uterine arteries	perioperative	Yes