[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100499394":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":32,"studyPopulation":20,"armGroups":33,"interventions":45,"overallOfficials":51,"centralContacts":56,"locations":62,"responsibleParty":81,"collaborators":20,"id":84,"slug":20,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":20,"eligibilityCriteria":89,"healthyVolunteers":85,"sex":90,"minAge":91,"maxAge":20,"enrollmentInfo":92,"targetDuration":20,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":20,"overallStatus":65,"whyStopped":20,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Hospital Universitari de Bellvitge","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":20},[9,13],{"measure":10,"description":11,"timeFrame":12},"Margin involvement","To compare the number of cases with affected margins in the definitive pathological anatomy, of the cases with intraoperative systematic shaving versus the group of no shaving","3 weeks after each surgery",{"measure":14,"description":15,"timeFrame":12},"Re-interventions","Demonstrate the reduction of second surgeries to widen affected margins in breast conserving surgery with the shaving technique",[17],{"measure":18,"description":19,"timeFrame":12},"Shaving versus intraoperative pathological study","Assess the possibility of replacing the intraoperative study of the margins with systematic shaving",null,{"allocation":22,"interventionModel":23,"interventionModelDescription":24,"primaryPurpose":25,"observationalModel":20,"timePerspective":20,"maskingInfo":26},"RANDOMIZED","PARALLEL","Randomized clinical trial","TREATMENT",{"masking":27,"maskingDescription":28,"whoMasked":29},"DOUBLE","Randomization will be performed by another investigator outside the operating room after lumpectomy.",[30,31],"PARTICIPANT","INVESTIGATOR","Patients with breast cancer who undergo breast-conserving surgery are randomized in the operating room after lumpectomy into 2 groups of 117 patients each: shaving\u002Fno-shaving (standard surgery).",[34,40],{"label":35,"type":36,"description":37,"interventionNames":38},"Shaving","EXPERIMENTAL","Subsequent to lumpectomy, a circumferential enlargement of all lumpectomy margins, including lateral, medial, superior, inferior, anterior, and posterior, approximately 5-10mm thick, will be resected.",[39],"Procedure: Margin shaving",{"label":41,"type":42,"description":43,"interventionNames":44},"No Shaving","ACTIVE_COMPARATOR","Standard lumpectomy",[39],[46],{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":20},"PROCEDURE","Margin shaving","In both cohorts, an intraoperative study of the margins will be carried out, and enlargement of those margins that are affected will be carried out as indicated by the pathologist. Subsequently, shaving is performed in case of being randomized to the study group or surgery is completed in the control group.",[41,35],[52],{"name":53,"affiliation":54,"role":55},"Amparo Garcia Tejedor, MDPhD","Hospital de Bellvitge. Instituto de Investigación Biomédica de Bellvitge (IDIBELL)","PRINCIPAL_INVESTIGATOR",[57],{"name":58,"role":59,"phone":60,"phoneExt":20,"email":61},"amparo garcia-tejedor, MDPhD","CONTACT","932607695","agarciat@bellvitgehospital.cat",[63],{"facility":64,"status":65,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"Hospital de Bellvitge","RECRUITING","L'Hospitalet de Llobregat","Barcelona","08907","Spain","ES",{"type":72,"coordinates":73},"Point",[74,75],2.10028,41.35967,{"lat":75,"lon":74},[78],{"name":79,"role":59,"phone":80,"phoneExt":20,"email":61},"Amparo Garcia-Tejedor, MDPhD","0034-932607695",{"type":55,"investigatorFullName":82,"investigatorTitle":83,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Amparo Garcia-Tejedor","Clinical Professor","100499394",false,"NCT05782686","Impact of Systematic Shaving on Margins","Reduction of Affected Margins in Conservative Surgery for Breast Cancer: Impact of Systematic Shaving in the Operating Room","Inclusion Criteria:\n\n1. Breast-conserving surgery.\n2. Imaging diagnosis as the only breast tumor focus according to mammography, breast ultrasound and\u002For nuclear magnetic resonance;\n3. Pathological diagnosis of carcinoma in situ or infiltrating\n4. Oncoplastic without associated flaps;\n\nExclusion Criteria:\n\n1. Male patients;\n2. Patients with a history of ipsilateral breast cancer.\n3. Oncoplastic that includes flaps\n4. Multifocality or multicentricity;\n5. Pregnant or lactating patient;\n6. Stage IV patients;\n7. Patients eligible for mastectomy;","FEMALE","18 Years",{"count":93,"type":94},234,"ESTIMATED","INTERVENTIONAL",[97],"NA","The objective of this clinical trial is to demonstrate the reduction of positive margins in the definitive pathology of patients undergoing breast-conserving surgery with the systematic shaving technique compared to conventional surgery, and the reduction of second interventions for margin enlargement.",[100,101,102],"Margin, Tumor-Free","Breast Cancer","Surgery","2025-09-08",{"date":105,"type":106},"2025-09-15","ACTUAL",{"date":108,"type":106},"2020-10-07",{"date":110,"type":94},"2026-10-16",{"name":5,"class":6},1]