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Temporary Clipping of the Uterine Arteries During Laparoscopic Myomectomy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01530802
Enrollment
166
Registered
2012-02-10
Start date
2007-01-31
Completion date
2009-12-31
Last updated
2012-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopic Myomectomy, Leiomyoma

Keywords

laparoscopic myomectomy, leiomyoma, blood loss, uterine artery

Brief summary

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

Interventions

PROCEDUREclipping of uterine arteries during laparoscopic myomectomy

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.

Sponsors

Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Blood loss during laparoscopic myomectomyperioperative (preop and postoperative day3)hemoglobin drop transfusion rate

Secondary

MeasureTime frameDescription
Patency of uterine artery after laparoscopic clippingperioperativeDoppler results of the uterine arteries

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026