Temporary Clipping of the Uterine Arteries During Laparoscopic Myomectomy

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

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

Conditions
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Leiomyoma, Laparoscopic Myomectomy

Intervention / Treatment
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* Procedure: clipping of uterine arteries during laparoscopic myomectomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Uterine artery clipped<br>Both uterine arteries are temporarily clipped by Yasargil clips during laparoscopic myomectomy. | Procedure: clipping of uterine arteries during laparoscopic myomectomy<br>* 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.<br>|
| No Intervention: Control group<br>Conventional laparoscopic myomectomy is performed. (No intervention to temporarily occlude uterine arteries is made) | Procedure: clipping of uterine arteries during laparoscopic myomectomy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss during laparoscopic myomectomy | hemoglobin drop transfusion rate | perioperative (preop and postoperative day3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patency of uterine artery after laparoscopic clipping | Doppler results of the uterine arteries | perioperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparoscopic myomectomy, leiomyoma, blood loss, uterine artery