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

March 11, 2025 updated by: Universitaire Ziekenhuizen KU Leuven
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Uterine fibroids, also known as myomas or leiomyomas, are benign smooth muscle neoplasms of the uterus. Uterine fibroids are the most common neoplasms affecting women of reproductive age (up to 70-80% at the age of 50)(1). As fibroids grow, they may induce clinical problems such as menorrhagia, abdominal pain, or infertility.(2,3) Removal of uterine fibroids (myomectomy) is a gynaecological surgical procedure performed most frequently through laparotomy or minimally invasive surgery such as conventional laparoscopic or robotically assisted surgery. Because of the straight-stick instruments with limited degree of freedom, the excision and suturing of the myoma can be rather cumbersome, not in the least because myomectomies may be associated with relatively profuse peri-operative bloodloss. Owing to its enhanced 3D vision and wristed instruments, robotically assisted surgery may be a more suitable surgical technique, especially in the case of multiple myomas, large myomas or posterior localization. Consequently, in recent years a gradual shift has been seen to the use of robotically assisted myomectomies.

However, control of the bleeding during a myomectomy can be a challenge, even in the hands of an experienced robotic surgeon. Various strategies have been developed to combat this scenario; including rectal or IV misoprostol, intramyometrial injection of bupivacaine with epinephrine or vasopressin, , tranexaminic acid IV or various ligation strategies. There is moderate quality evidence for some of these interventions. Recently, the use of clips to temporary occlude the uterine artery for myomectomy with conventional laparoscopy for prevention of blood loss was validated in several studies, including 2 randomized controlled trials. To enhance hemostasis, recent articles described a technique to temporary clip both the uterine artery and infundibulopelvic artery with conventional laparoscopy, also resulting in fewer intra-operative bleeding compared to no artery clipping. The possible benefit of these ligation technique has never been studied in the setting of robotically-assisted myomectomies. On the one hand, RAM may involve more complex cases due to myoma size, localization or multiple myomas, and on the other hand, bleeding control may also be better with robotic surgery. This makes a prediction of the usefulness of this technique difficult, in terms of reducing blood loss.

Estimated blood loss remains a difficult outcome to reliably quantify, especially when using only visual parameters. During RAM, often only suction is used, making the estimation easier in comparison to open surgery, for which a variety of compresses and suction is used. This study will work with multiple primary endpoints, combining estimated blood loss over 500 mL, the need for a peri-operative blood transfusion or a hemoglobin drop exceeding 2 g/dL.

Other secondary outcomes will include complication rate, the operation time, postoperative pain and the need for additional hemostatic measures. In the literature, the risk of changes in ovarian reserve is also investigated, however it proved not significant and this was only a theoretical risk in the context of temporary clipping the infundibulopelvic artery, which is the main blood supply of the ovary. In this study, which will involve temporary clipping the utero-ovarian ligmant, there is no risk for a decrease in ovarian reserve.

Study Type

Interventional

Enrollment (Estimated)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • Recruiting
        • University Hospitals Leuven
        • Contact:
  • France
      • Paris, France
        • Not yet recruiting
        • Department of Gynecology and Obstetrics, Hopital Bichat
        • Contact:
      • Rennes, France
        • Not yet recruiting
        • Service de gynécologie, Centre Hospitalier Universitaire de Rennes
        • Contact:
          • Vincent Lavoué, MD, PhD
  • Netherlands
      • Amsterdam, Netherlands

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Participants eligible for inclusion in this Trial must meet all of the following criteria:

  1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
  2. Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner.
  3. Female
  4. Age: 18-50 years
  5. Myomas, eligible for myomectomy, with the exclusion of FIGO 7-8 myomas.

Exclusion Criteria:

Participants eligible for this Trial must not meet any of the following criteria:

  1. Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol
  2. Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial
  3. Participation in an interventional Trial with an investigational medicinal product (IMP) or device
  4. Patient refusal to participate in the Trial
  5. (Possible) malignancy
  6. any contra indication for a laparoscopic or robotic surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Temporary artery clipping
Patients undergoing a robotically-assisted myomectomies, with temporary clipping of the uterine arteries and the utero-ovarian ligmants.
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.
Active Comparator: Control
Patients undergoing a robotically-assisted myomectomies, without temporary clipping of the uterine arteries and the utero-ovarian ligmants.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peri-operative blood loss: Estimated blood loss
Time Frame: 1 week

Multiple primary endpoints will be used to asses the blood loss:

- Estimated blood loss >500 mL
1 week
Peri-operative blood loss: Hemoglobin drop perioperatively >2g/dL
Time Frame: 1 day

Multiple primary endpoints will be used to asses the blood loss:

- Hemoglobin drop perioperatively >2g/dL (difference between hemoglobin preoperatively and postoperatively)
1 day
Peri-operative blood loss: Need for peri-operative blood transfusion
Time Frame: 1 week

Multiple primary endpoints will be used to asses the blood loss:

- Need for peri-operative blood transfusion
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospitalisation time
Time Frame: 6 weeks
Number of postoperative nights the patient had to stay in the hospital.
6 weeks
Operation time in minutes
Time Frame: 1 day
Total surgical time, from the completion of anesthesia induction untill the end of surgery (in minutes)
1 day
Number of patients with complications postoperatively, graded by Clavien Dindo classification
Time Frame: 6 weeks

The Clavien Dindo classification is a validated tool to quantitatively assess postoperative complications.

Grade 0: No complications Grade 1: Any deviation from normal postoperative course, without requiring intervention Grade 2: Requiring pharmacological treatment Grade 3: Requiring surgical, endoscopic or radiological intervention Grade 4: Life-treathening complication requiring intermediate or intensive care Grade 5: Death of a patient
6 weeks
Number of patients requiring secondary hemostatic measures
Time Frame: 1 day

Was there a need for non-routine hemostatic measures, such as:

  • Tranexamic acid
  • Misoprostol
  • Oxytocin
  • Embolisation
  • Local application of sealant patch or glue (e.g TachoSil or Tisseel)
  • Hysterectomy
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Collaborators

Amsterdam UMC, location VUmc
Rennes University Hospital
Bichat Hospital

Investigators

  • Principal Investigator: Wouter Froyman, MD, PhD, Universitaire Ziekenhuizen KU Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2023

Primary Completion (Estimated)

May 30, 2025

Study Completion (Estimated)

May 30, 2025

Study Registration Dates

First Submitted

July 13, 2023

First Submitted That Met QC Criteria

February 12, 2024

First Posted (Actual)

February 21, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 11, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • s67279

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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