protocolSection identificationModule nctId: NCT06302361, orgStudyIdInfo id: 23/54225, briefTitle: Lymphovenous Anastomosis for Breast Cancer Lymphedema, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Odense University Hospital, class: OTHER, collaborators name: Vejle Hospital, collaborators name: Zealand University Hospital, collaborators name: Herlev and Gentofte Hospital, descriptionModule briefSummary: This multi-center cohort study focuses on evaluating the efficacy of lymphovenous anastomosis (LVA) for treating pitting lymphedema in female breast cancer survivors. Conducted across multiple centers in Denmark, including Odense University Hospital, Herlev Hospital, Lillebaelt Hospital Vejle, and Zealand University Hospital, it aims to assess LVA's impact on reducing arm volume and improving quality of life in patients with upper extremity lymphedema secondary to breast cancer treatment.Eligible participants are adult women with unilateral arm lymphedema who show active pitting and identifiable lymphatic vessels via indocyanine green lymphography. Inclusion involves informed consent and the ability to complete Danish questionnaires.Patients are recruited from the outpatient clinics of the participating hospitals and will undergo LVA surgery under either local or general anesthesia. Following the intervention, patients are seen for data collection up to twelve months.The study measures outcomes like arm volume changes through water displacement volumetry and arm circumferential measurements, body composition via bioimpedance, health-related quality of life through LYMPH-Q, general quality of life through SF-36, arm function via DASH, and anastomosis patency via ICG lymphography. Additionally, changes in ICG lymphography images, arm fibrosis via SkinFibroMeter, and surgery duration are evaluated.The study adheres to ethical guidelines, ensuring patient safety and the integrity of the research., conditionsModule conditions: Lymphedema, conditions: Lymphedema Arm, conditions: Breast Cancer Lymphedema, conditions: Lymphedema, Secondary, conditions: Lymphedema; Surgical, conditions: Lymphedema of Upper Limb, conditions: Lymphedema, Breast Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Multi-center cohort study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 47, type: ESTIMATED, armsInterventionsModule interventions name: Lymphovenous anastomosis (LVA), outcomesModule primaryOutcomes measure: Arm volume (Water Displacement), primaryOutcomes measure: Arm volume (Arm Circumferences), secondaryOutcomes measure: Health-related quality of life (LYMPH-Q), secondaryOutcomes measure: General quality of life (SF-36), secondaryOutcomes measure: Arm and shoulder function (DASH), secondaryOutcomes measure: L-Dex, secondaryOutcomes measure: LVA patency, secondaryOutcomes measure: Skin Fibrosis, secondaryOutcomes measure: Surgery duration, secondaryOutcomes measure: Body composition, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Plastic Surgery, Odense University Hospital, status: RECRUITING, city: Odense, state: Region Of Southern Denmark, zip: 5000, country: Denmark, contacts name: Caroline Lilja, MD, role: CONTACT, phone: +4560555340, email: caroline.lilja@rsyd.dk, geoPoint lat: 55.39594, lon: 10.38831, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-02-07, uploadDate: 2024-03-04T05:57, filename: Prot_SAP_000.pdf, size: 934504, hasResults: False