Temporary Clipping of the Uterine Arteries During Laparoscopic Myomectomy

Sponsor

Charite University, Berlin, Germany (Other)

Overall Status

Completed

CT.gov ID

NCT01530802

Collaborator

(none)

166

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

2.4

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

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 :

Jan 1, 2007

Study Completion Date :

Dec 1, 2009

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

Blood loss during laparoscopic myomectomy [perioperative (preop and postoperative day3)]
hemoglobin drop transfusion rate

Secondary Outcome Measures

Patency of uterine artery after laparoscopic clipping [perioperative]
Doppler results of the uterine arteries

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Charite University Hospital	Berlin		Germany	12200
2	Bernd Holthaus	Damme		Germany

Sponsors and Collaborators

Charite University, Berlin, Germany

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01530802

Other Study ID Numbers:

EA4/07906

First Posted:

Feb 10, 2012

Last Update Posted:

Feb 10, 2012

Last Verified:

Jun 1, 2010

Keywords provided by , ,

laparoscopic myomectomy, leiomyoma, blood loss, uterine artery

Additional relevant MeSH terms:

Leiomyoma

Myofibroma

Study Results

No Results Posted as of Feb 10, 2012