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

NCT ID: NCT07182045

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-18
• Study Completion Date: 2029-09-30

Brief Summary

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.

Detailed 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.

Conditions

Myoma; Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Temporary vessel clamps

Use of temporary laparoscopic vessel clamps on uterine and ovarian vessels

Group Type: EXPERIMENTAL

Temporary clamping of uterine and ovarian vessels

Intervention Type: OTHER

Surgeon will temporarily clamp uterine and ovarian vessels.

No Temporary vessel clamps

No use of vessel clamps

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Temporary clamping of uterine and ovarian vessels

Surgeon will temporarily clamp uterine and ovarian vessels.

Intervention Type: OTHER

Other Intervention Names

Vessel occlusion

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Randa Jalloul

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Randa Jalloul, MD

Role: CONTACT

randa.j.jalloul@uth.tmc.edu

3137128603

Other Identifiers

HSC-MS-25-0413

Identifier Type: -

Identifier Source: org_study_id