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RECRUITING
NCT06269809
NA

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

Sponsor: Universitaire Ziekenhuizen KU Leuven

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

82

Start Date

2023-05-04

Completion Date

2025-05-30

Last Updated

2025-03-14

Healthy Volunteers

No

Conditions

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

Locations (4)

University Hospitals Leuven

Leuven, Belgium

Department of Gynecology and Obstetrics, Hopital Bichat

Paris, France

Service de gynécologie, Centre Hospitalier Universitaire de Rennes

Rennes, France

Amsterdam UMC, locatie VUmc

Amsterdam, Netherlands