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Temporary Artery Clipping for Robotically-assisted Myomectomy, a Multicentric Randomized Controlled Trial

NCT06269809 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2025-03-14

No results posted yet for this study

Summary

This study aims to investigate the efficacy of temporary clipping of the uterine artery and utero-ovarian ligament during robotically assisted myomectomy (RAM) for uterine fibroids. While RAM is increasingly used for myomectomy, bleeding control remains challenging. Temporary clipping of arteries has shown promise in conventional laparoscopy but has not been studied in RAM. This randomized controlled trial will assess primary endpoints such as estimated blood loss, need for transfusion, and hemoglobin drop, alongside secondary outcomes like complication rates and operation time.

Conditions

  • Fibroid Uterus

Interventions

PROCEDURE

Temporary clipping of the uterine arteries and the utero-ovarian ligmants.

Temporary clipping of the uterine arteries and the utero-ovarian ligaments using laparoscopic clips/bulldog clamps, during robotically assisted myomectomy.

PROCEDURE

No temporary clipping of the uterine arteries and the utero-ovarian ligmants.

Robotically assisted myomectomy, for which no temporary clipping of the uterine arteries and the utero-ovarian ligaments

Sponsors & Collaborators

  • Amsterdam UMC, location VUmc

    collaborator OTHER

  • Bichat Hospital

    collaborator OTHER

  • Rennes University Hospital

    collaborator OTHER

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Wouter Froyman, MD, PhD · Universitaire Ziekenhuizen KU Leuven

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-04
Primary Completion
2025-05-30
Completion
2025-05-30

Countries

  • Belgium
  • France
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06269809 on ClinicalTrials.gov