Impact of Uterine and Ovarian Vessel Occlusion on Blood Loss in High Burden Minimally Invasive Myomectomy. (Myo-Bleed)

The University of Texas System (UT)

Status: Not yet enrolling

Conditions: Surgery; Myoma

Treatments: Other: Temporary clamping of uterine and ovarian vessels

Study type: Interventional

Funder types: Other

Identifiers

NCT07182045

HSC-MS-25-0413

Details and patient eligibility

About

This study hypothesizes that temporary bilateral uterine and utero-ovarian artery occlusion with laparoscopic clamps at time of minimally invasive myomectomy will lead to a decreased blood loss at time of myomectomy compared to minimally invasive myomectomy without temporary occlusion.

Full description

Background: Leiomyomas are the most common benign tumor of the uterus and affect approximately 70-80% of the population with a uterus . Patients who opt to undergo treatment for a fibroid uterus have a variety of options including medical management, embolization, or surgical management; Historically surgical management involved hysterectomy; however, myomectomy has become more popular as a uterine sparing option. Current data supports that minimally invasive myomectomy is associated with lower morbidity and blood loss than traditional abdominal surgery. With advances in Minimally invasive myomectomy (MIS). There continues to be interest in methods to better improve intraoperative and postoperative outcomes. There is currently support for universal use of intramural vasopressin at time of myomectomy and a growing body of evidence to support temporary bilateral occlusion of the uterine and/or uteroovarian arteries at time of myomectomy to decrease blood loss.

High myoma burden is associated with an increased blood loss at time of surgical management.

Previous studies assessing the utility in temporary occlusion of the uterine and/or utero-ovarian vessels have not specifically evaluated the impact on high myoma burden individuals. As higher myoma burden is addressed in a minimally invasive fashion, it is important to specifically evaluate techniques to optimize these procedures. This study will specifically evaluate the effect of temporary bilateral uterine artery and utero-ovarian occlusion with laparoscopic clamps at the time of minimally invasive myomectomy.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patient undergoing minimally invasive myomectomy with either a single intramural or Submucosal fibroid =/>5cm or
• Patients undergoing minimally invasive Myomectomy with =/> 5 fibroids

Exclusion criteria

• Pregnancy,
• Age <18yo,
• Patients undergoing concomitant surgery such as endometriosis surgery,
• Suspected malignancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

Temporary vessel clamps

Experimental group

Description:

Use of temporary laparoscopic vessel clamps on uterine and ovarian vessels

Treatment:

Other: Temporary clamping of uterine and ovarian vessels

No Temporary vessel clamps

No Intervention group

Description:

No use of vessel clamps