RecruitingNot ApplicableNCT06269809

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

Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

82 participants

Start Date

May 4, 2023

Study Type

INTERVENTIONAL

Conditions

Fibroid Uterus

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two surgical approaches for women having robotic surgery to remove uterine fibroids (noncancerous growths in the uterus). It looks at whether temporarily clamping the uterine arteries during surgery reduces blood loss. **You may be eligible if...** - You are a woman between 18 and 50 years old - You have uterine fibroids that require surgical removal - You are using a reliable form of birth control **You may NOT be eligible if...** - You are post-menopausal or outside the age range - You do not meet birth control requirements - You have other conditions that make surgery higher risk Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURETemporary 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.

PROCEDURENo 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