Temporary Clipping of the Uterine Arteries During Laparoscopic Myomectomy

Not Applicable

Completed

• Conditions: Leiomyoma; Laparoscopic Myomectomy
• Interventions: Procedure: clipping of uterine arteries during laparoscopic myomectomy

• Registration Number: NCT01530802
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study Completion: 2009-12
• Status Verified: 2010-06
• Study First Submitted: 2010-11-01
• Study First Submitted QC: 2012-02-09
• Last Update Submitted: 2012-02-09
• Study First Posted: 2012-02-10
• Last Update Posted: 2012-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 166

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Uterine artery clipped	clipping of uterine arteries during laparoscopic myomectomy	Both uterine arteries are temporarily clipped by Yasargil clips during laparoscopic myomectomy.
Control group	clipping of uterine arteries during laparoscopic myomectomy	Conventional laparoscopic myomectomy is performed. (No intervention to temporarily occlude uterine arteries is made)

Primary Outcome Measures

Name	Time	Method
Blood loss during laparoscopic myomectomy	perioperative (preop and postoperative day3)	hemoglobin drop transfusion rate

Secondary Outcome Measures

Name	Time	Method
Patency of uterine artery after laparoscopic clipping	perioperative	Doppler results of the uterine arteries

Trial Locations

Locations (2)

Bernd Holthaus; 🇩🇪 Damme, Germany

Charite University Hospital; 🇩🇪 Berlin, Germany