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

NCT06269809 | Recruiting

• 1 other identifier: s67279
• Study Type: interventional
• Target: 82
• Locations: 3 countries
• Sites: 4

Brief 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

Keywords

myomectomy; fibroid; myoma; blood loss; temporary artery clipping; hemostatic measures

Outcome Measures

Primary Outcomes (3)

• Peri-operative blood loss: Estimated blood loss

  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

  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

  Multiple primary endpoints will be used to asses the blood loss: \- Need for peri-operative blood transfusion

  1 week

Secondary Outcomes (4)

• Hospitalisation time

  6 weeks

• Operation time in minutes

  1 day

• Number of patients with complications postoperatively, graded by Clavien Dindo classification

  6 weeks

• Number of patients requiring secondary hemostatic measures

  1 day

Study Arms (2)

Temporary artery clipping

EXPERIMENTAL

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.

Control

ACTIVE COMPARATOR

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.

Interventions

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

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

Temporary artery clipping

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

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
• 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.
• Female
• Age: 18-50 years

You may not qualify if:

• Participants eligible for this Trial must not meet any of the following criteria:
• Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol
• Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial
• Participation in an interventional Trial with an investigational medicinal product (IMP) or device
• Patient refusal to participate in the Trial
• (Possible) malignancy
• any contra indication for a laparoscopic or robotic surgery

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Amsterdam UMC, location VUmc: collaborator
• Bichat Hospital: collaborator
• Rennes University Hospital: collaborator

Study Sites (4)

University Hospitals Leuven

Leuven, 3000, Belgium

RECRUITING

Department of Gynecology and Obstetrics, Hopital Bichat

Paris, France

NOT YET RECRUITING

Service de gynécologie, Centre Hospitalier Universitaire de Rennes

Rennes, France

NOT YET RECRUITING

Amsterdam UMC, locatie VUmc

Amsterdam, Netherlands

NOT YET RECRUITING

Related Publications (14)

• Williams VS, Jones G, Mauskopf J, Spalding J, DuChane J. Uterine fibroids: a review of health-related quality of life assessment. J Womens Health (Larchmt). 2006 Sep;15(7):818-29. doi: 10.1089/jwh.2006.15.818.

  PMID: 16999637 BACKGROUND

• Pritts, E. A., & Olive, D. L. (2012). When Should Uterine Fibroids Be Treated? Current Obstetrics and Gynecology Reports. https://doi.org/10.1007/s13669-012-0010-y

  BACKGROUND

• Stewart EA, Cookson CL, Gandolfo RA, Schulze-Rath R. Epidemiology of uterine fibroids: a systematic review. BJOG. 2017 Sep;124(10):1501-1512. doi: 10.1111/1471-0528.14640. Epub 2017 May 13.

  PMID: 28296146 BACKGROUND

• Aendekerk, S., Verguts, J., Housmans, S., & Timmerman, D. (2019). Implementing robotic assisted myomectomy in surgical practice - a retrospective cohort study. Gynecological Surgery. https://doi.org/10.1186/s10397-019-1059-7

  BACKGROUND

• Herrinton LJ, Raine-Bennett T, Liu L, Alexeeff SE, Ramos W, Suh-Burgmann B. Outcomes of Robotic Hysterectomy for Treatment of Benign Conditions: Influence of Patient Complexity. Perm J. 2020;24:19.035. doi: 10.7812/TPP/19.035. Epub 2019 Dec 18.

  PMID: 31905335 BACKGROUND

• Winter ML, Leu SY, Lagrew DC Jr, Bustillo G. Cost comparison of robotic-assisted laparoscopic hysterectomy versus standard laparoscopic hysterectomy. J Robot Surg. 2015 Dec;9(4):269-75. doi: 10.1007/s11701-015-0526-z. Epub 2015 Jul 30.

  PMID: 26530837 BACKGROUND

• Kongnyuy EJ, Wiysonge CS. Interventions to reduce haemorrhage during myomectomy for fibroids. Cochrane Database Syst Rev. 2014 Aug 15;2014(8):CD005355. doi: 10.1002/14651858.CD005355.pub5.

  PMID: 25125317 BACKGROUND

• Ji L, Jin L, Hu M. Laparoscopic Myomectomy with Temporary Bilateral Uterine Artery Occlusion Compared with Traditional Surgery for Uterine Myomas: Blood Loss and Recurrence. J Minim Invasive Gynecol. 2018 Mar-Apr;25(3):434-439. doi: 10.1016/j.jmig.2017.06.032. Epub 2017 Sep 21.

  PMID: 28943191 BACKGROUND

• Vercellino G, Erdemoglu E, Joe A, Hopfenmueller W, Holthaus B, Kohler C, Schneider A, Hasenbein K, Chiantera V. Laparoscopic temporary clipping of uterine artery during laparoscopic myomectomy. Arch Gynecol Obstet. 2012 Nov;286(5):1181-6. doi: 10.1007/s00404-012-2419-y. Epub 2012 Jun 20.

  PMID: 22714065 BACKGROUND

• Hiratsuka D, Isono W, Tsuchiya A, Okamura A, Fujimoto A, Nishii O. The effect of temporary uterine artery ligation on laparoscopic myomectomy to reduce intraoperative blood loss: A retrospective case-control study. Eur J Obstet Gynecol Reprod Biol X. 2022 Aug 8;15:100162. doi: 10.1016/j.eurox.2022.100162. eCollection 2022 Aug.

  PMID: 36035234 BACKGROUND

• Kim HC, Song T. Temporary simultaneous two-arterial occlusion for reducing operative blood loss during laparoscopic myomectomy: a randomized controlled trial. Surg Endosc. 2019 Jul;33(7):2114-2120. doi: 10.1007/s00464-018-6482-8. Epub 2018 Oct 17.

  PMID: 30334154 BACKGROUND

• Coll S, Feliu S, Montero C, Pellise-Tintore M, Tresserra F, Rodriguez I, Barri-Soldevila PN. Evolution of laparoscopic myomectomy and description of two hemostatic techniques in a large teaching gynecological center. Eur J Obstet Gynecol Reprod Biol. 2021 Oct;265:181-189. doi: 10.1016/j.ejogrb.2021.08.023. Epub 2021 Aug 26.

  PMID: 34509877 BACKGROUND

• Rothermel LD, Lipman JM. Estimation of blood loss is inaccurate and unreliable. Surgery. 2016 Oct;160(4):946-953. doi: 10.1016/j.surg.2016.06.006. Epub 2016 Aug 17.

  PMID: 27544540 BACKGROUND

• Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.

  PMID: 19638912 BACKGROUND

MeSH Terms

Conditions

Leiomyoma; Myoma; Hemorrhage

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wouter Froyman, MD, PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan Timmerman, MD

CONTACT

+3216348826; stefan.timmerman@uzleuven.be

Wouter Froyman, MD, PhD

CONTACT

+3216344202; wouter.froyman@uzleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicentric non-blinded randomized controlled trial

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: February 21, 2024
• Study Start: May 4, 2023
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); FR (2); BE (1)