Temporary Clipping of the Uterine Arteries During Laparoscopic Myomectomy

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

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Key information

Conditions

Leiomyoma Hemorrhage Laparoscopic Myomectomy Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Charite University Hospital, Berlin, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

clipping of uterine arteries during laparoscopic myomectomy

Procedure

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.

Primary outcomes

Blood loss during laparoscopic myomectomy

Time frame: perioperative (preop and postoperative day3)

hemoglobin drop transfusion rate

Secondary outcomes

Patency of uterine artery after laparoscopic clipping

Time frame: perioperative

Doppler results of the uterine arteries

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

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

Important dates

Study start: 2007
Study completion: 2009
First posted: Feb 10, 2012
Registry last updated: Feb 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed