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NCT Number: NCT07182045

Impact of Uterine and Ovarian Vessel Occlusion on Blood Loss in High Burden Minimally Invasive Myomectomy.

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Randa Jalloul, MD

CONTACT

[email protected]

713-486-7700

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Temporary clamping of uterine and ovarian vessels

Other

Surgeon will temporarily clamp uterine and ovarian vessels.

Other names: Vessel occlusion

Primary outcomes

  1. Estimated blood loss

    Time frame: Intraoperative (during surgery, which is < 24 hours)

    Estimated blood loss during the surgery between groups, calculated by suction prior to irrigation.

Study contacts

Contact information is provided by the study sponsor or research team.

Randa Jalloul, MD

CONTACT

[email protected]

3137128603

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Acronym: Myo-Bleed

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Sep 19, 2025
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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