Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
ID06269809

Temporary Artery Clipping for Robotically-assisted Myomectomy for Uterine Fibroids A Multicentric Randomized Controlled Trial

Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2025-03-14

82

Participants Needed

4

Research Sites

N/A

Total Duration

On this page

Sponsors

U

Universitaire Ziekenhuizen KU Leuven

Lead Sponsor

A

Amsterdam UMC, location VUmc

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of temporarily clipping the uterine artery and utero-ovarian ligament during robotically assisted myomectomy (RAM) for women with uterine fibroids. Uterine fibroids are common non-cancerous tumors that can cause heavy bleeding, pain, or infertility. While RAM is increasingly used for fibroid removal, controlling bleeding during surgery remains challenging. This randomized controlled trial aims to assess blood loss, need for transfusion, and hemoglobin changes, along with complications and operation time. The study compares two groups: one receiving temporary clipping of the uterine arteries and utero-ovarian ligaments using laparoscopic clips during RAM, and the other undergoing RAM without this clipping. The procedure involves temporarily blocking blood flow to reduce bleeding. Both groups undergo robotically assisted myomectomies, and the clipping technique has been studied previously in conventional laparoscopy but not yet in RAM. Participants will be monitored for blood loss during surgery, hemoglobin levels, and any need for blood transfusions within one week. Secondary assessments include operation duration, hospital stay length, complication rates, postoperative pain, and use of additional bleeding control methods. The total follow-up includes monitoring for complications up to six weeks after surgery, ensuring detailed evaluation of safety and surgical outcomes.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Provide voluntary written informed consent before screening
  • Use highly effective birth control methods or have a vasectomised partner
  • Female gender
  • Age between 18 and 50 years
  • Diagnosed with uterine fibroids eligible for myomectomy excluding FIGO types 7 and 8
Not Eligible

You will not qualify if you...

  • Any condition that might risk participant safety or protocol compliance
  • Prior or concurrent treatments risking safety or trial integrity
  • Participation in another interventional trial with investigational products
  • Refusal to participate
  • Possible malignancy
  • Contraindications for laparoscopic or robotic surgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

screening and enrollment visit

Surgery and Immediate Post-operative Care

Duration - 1 day

Participants undergo robotically-assisted myomectomy with or without temporary clipping of the uterine arteries and the utero-ovarian ligaments to control bleeding during surgery.

1 surgical visit (in-person)

Post-operative Follow-up

Duration - up to 6 weeks

Participants are monitored for post-operative complications, hospitalisation time, and recovery after surgery.

approximately 3 follow-up visits

Trial Site Locations

Total: 4 locations

1

University Hospitals Leuven

Leuven, Belgium, 3000

Actively Recruiting

2

Department of Gynecology and Obstetrics, Hopital Bichat

Paris, France

Not Yet Recruiting

3

Service de gynécologie, Centre Hospitalier Universitaire de Rennes

Rennes, France

Not Yet Recruiting

4

Amsterdam UMC, locatie VUmc

Amsterdam, Netherlands

Not Yet Recruiting

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Research Team

S

Stefan Timmerman, MD

W

Wouter Froyman, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Laparoscopic Myomectomy with Temporary Bilateral Uterine Artery Occlusion Compared with Traditional Surgery for Uterine Myomas: Blood Loss and Recurrence.

Limei Ji, Lanying Jin, Min Hu

https://pubmed.ncbi.nlm.nih.gov/28943191

The effect of temporary uterine artery ligation on laparoscopic myomectomy to reduce intraoperative blood loss: A retrospective case-control study.

Daiki Hiratsuka, Wataru Isono, Akira Tsuchiya...

https://pubmed.ncbi.nlm.nih.gov/36035234

Temporary simultaneous two-arterial occlusion for reducing operative blood loss during laparoscopic myomectomy: a randomized controlled trial.

Hwa Cheong Kim, Taejong Song

https://pubmed.ncbi.nlm.nih.gov/30334154

Evolution of laparoscopic myomectomy and description of two hemostatic techniques in a large teaching gynecological center.

Sandra Coll, Silvia Feliu, Claudia Montero...

https://pubmed.ncbi.nlm.nih.gov/34509877