Temporary Clipping of the Uterine Arteries During Laparoscopic Myomectomy

Charité University Medicine Berlin

Status: Completed

Conditions: Laparoscopic Myomectomy; Leiomyoma

Treatments: Procedure: clipping of uterine arteries during laparoscopic myomectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01530802

EA4/07906

Details and patient eligibility

About

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

Enrollment: 166 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No 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.

Trial design

166 participants in 2 patient groups

Uterine artery clipped

Experimental group

Description:

Both uterine arteries are temporarily clipped by Yasargil clips during laparoscopic myomectomy.

Treatment:

Procedure: clipping of uterine arteries during laparoscopic myomectomy

Control group

No Intervention group

Description:

Conventional laparoscopic myomectomy is performed. (No intervention to temporarily occlude uterine arteries is made)

Treatment:

Procedure: clipping of uterine arteries during laparoscopic myomectomy