NCT07182045

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
41mo left

Started Sep 2025

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress16%
Sep 2025Sep 2029

First Submitted

Initial submission to the registry

September 16, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

September 18, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 19, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2029

Last Updated

September 23, 2025

Status Verified

September 1, 2025

Enrollment Period

3 years

First QC Date

September 16, 2025

Last Update Submit

September 17, 2025

Conditions

MyomaSurgery

Keywords

myomablood loss

Outcome Measures

Primary Outcomes (1)

  • Estimated blood loss

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

    Intraoperative (during surgery, which is < 24 hours)

Study Arms (2)

Temporary vessel clamps

EXPERIMENTAL

Use of temporary laparoscopic vessel clamps on uterine and ovarian vessels

Other: Temporary clamping of uterine and ovarian vessels

No Temporary vessel clamps

NO INTERVENTION

No use of vessel clamps

Interventions

Temporary clamping of uterine and ovarian vesselsOTHER

Surgeon will temporarily clamp uterine and ovarian vessels.

Also known as: Vessel occlusion
Temporary vessel clamps

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPatients with female reproductive organs
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

MyomaHemorrhage

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Randa Jalloul, MD

CONTACT

3137128603randa.j.jalloul@uth.tmc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 16, 2025

First Posted

September 19, 2025

Study Start

September 18, 2025

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

September 30, 2029

Last Updated

September 23, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share