Temporary Clipping of the Uterine Arteries During Laparoscopic Myomectomy

NCT01530802 | Completed

• 1 other identifier: EA4/07906
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Leiomyoma; Laparoscopic Myomectomy

Keywords

laparoscopic myomectomy, leiomyoma, blood loss, uterine artery

Outcome Measures

Primary Outcomes (1)

• Blood loss during laparoscopic myomectomy

  hemoglobin drop transfusion rate

  perioperative (preop and postoperative day3)

Secondary Outcomes (1)

• Patency of uterine artery after laparoscopic clipping

  perioperative

Study Arms (2)

Uterine artery clipped

EXPERIMENTAL

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

Procedure: clipping of uterine arteries during laparoscopic myomectomy

Control group

NO INTERVENTION

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

Procedure: clipping of uterine arteries during laparoscopic myomectomy

Interventions

clipping of uterine arteries during laparoscopic myomectomy PROCEDURE

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.

Control group; Uterine artery clipped

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (2)

Charite University Hospital

Berlin, 12200, Germany

Location

Bernd Holthaus

Damme, Germany

Location

MeSH Terms

Conditions

Leiomyoma; Hemorrhage

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 2010
• First Posted: February 10, 2012
• Study Start: January 1, 2007
• Study Completion: December 1, 2009
• Last Updated: February 10, 2012

Record last verified: 2010-06

Locations

DE (2)