Temporary Clipping of the Uterine Arteries During Laparoscopic Myomectomy

Charite University, Berlin, Germany166 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

SINGLE

Enrollment

166

Conditions

Leiomyoma Laparoscopic Myomectomy

Interventions

clipping of uterine arteries during laparoscopic myomectomyPROCEDURE

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

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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.

Locations (2)

Charite University Hospital

Berlin, Germany

Bernd Holthaus

Damme, Germany

Outcomes

Primary Outcomes

Blood loss during laparoscopic myomectomy

hemoglobin drop transfusion rate

Time frame: perioperative (preop and postoperative day3)

Secondary Outcomes

Patency of uterine artery after laparoscopic clipping

Doppler results of the uterine arteries

Time frame: perioperative

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.