protocolSection identificationModule nctId: NCT06269809, orgStudyIdInfo id: s67279, briefTitle: Temporary Artery Clipping for Robotically-assisted Myomectomy, a Multicentric Randomized Controlled Trial, acronym: TACROM, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-04, primaryCompletionDateStruct date: 2025-05-30, completionDateStruct date: 2025-05-30, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Universitaire Ziekenhuizen KU Leuven, class: OTHER, collaborators name: Amsterdam UMC, location VUmc, collaborators name: Bichat Hospital, collaborators name: Rennes University Hospital, descriptionModule briefSummary: 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., conditionsModule conditions: Fibroid Uterus, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Multicentric non-blinded randomized controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 82, type: ESTIMATED, armsInterventionsModule interventions name: Temporary clipping of the uterine arteries and the utero-ovarian ligmants., interventions name: No temporary clipping of the uterine arteries and the utero-ovarian ligmants., outcomesModule primaryOutcomes measure: Peri-operative blood loss: Estimated blood loss, primaryOutcomes measure: Peri-operative blood loss: Hemoglobin drop perioperatively >2g/dL, primaryOutcomes measure: Peri-operative blood loss: Need for peri-operative blood transfusion, secondaryOutcomes measure: Hospitalisation time, secondaryOutcomes measure: Operation time in minutes, secondaryOutcomes measure: Number of patients with complications postoperatively, graded by Clavien Dindo classification, secondaryOutcomes measure: Number of patients requiring secondary hemostatic measures, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospitals Leuven, status: RECRUITING, city: Leuven, zip: 3000, country: Belgium, contacts name: Wouter Froyman, MD, PhD, role: CONTACT, phone: +3216342612, email: wouter.froyman@uzleuven.be, geoPoint lat: 50.87959, lon: 4.70093, locations facility: Department of Gynecology and Obstetrics, Hopital Bichat, status: NOT_YET_RECRUITING, city: Paris, country: France, contacts name: Martin Koskas, MD, PhD, role: CONTACT, email: martin.koskas@aphp.fr, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Service de gynécologie, Centre Hospitalier Universitaire de Rennes, status: NOT_YET_RECRUITING, city: Rennes, country: France, contacts name: Vincent Lavoué, MD, PhD, role: CONTACT, geoPoint lat: 48.11198, lon: -1.67429, locations facility: Amsterdam UMC, locatie VUmc, status: NOT_YET_RECRUITING, city: Amsterdam, country: Netherlands, contacts name: Robert De Leeuw, MD, PhD, role: CONTACT, email: r.a.deleeuw@amsterdamumc.nl, geoPoint lat: 52.37403, lon: 4.88969, hasResults: False