[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564111":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":32,"locations":40,"responsibleParty":66,"collaborators":18,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":18,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":90,"overallStatus":43,"whyStopped":18,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"University of Rome Tor Vergata","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Green Breast Surgery","EXPERIMENTAL","Preoperative assessment:\n\nCounsel patients before admission.\n\n* Encourage 1 month of no alcohol and smoking before surgery.\n* Recommend weight loss for BMI \\> 30 with exercise.\n\nOperative assessment:\n\n* Admit to Day Surgery Unit.\n* Allow clear liquids until 2 hours before surgery.\n* Give maltodextrin 2 hours prior to surgery.\n* Prescribe antibiotic prophylaxis if needed.\n* Prescribe post-op anti-nausea\u002Fvomiting medication.\n* Use Awake Breast Surgery Protocol with Peripheral Nerve Blocks (ESP or PECS1).\n* Follow Intercollage Green Theatre checklist.\n* Post-operative assessment:\n\nApply personalized DVT prophylaxis.\n\n* Allow food and water shortly after surgery.\n* Encourage mobilization a few hours post-surgery.\n* Use telemedicine for first follow-ups and later as needed.\n* Scheduled Time Frame pain (NRS scale) and quality of life (PSQ-18, SF-36, QoL, Breast-Q, TSQ-WT) assessment\n* Check for complications 30 days after surgery.",[13],"Procedure: Green Breast Surgery Protocol",{"label":15,"type":16,"description":17,"interventionNames":18},"Conventional Surgery","NO_INTERVENTION","Preoperative assessment:\n\nCounsel patients before admission.\n\n* Encourage 1 month of no alcohol and smoking before surgery.\n* Recommend weight loss for BMI \\> 30 with exercise.\n\nOperative assessment:\n\n* Admit to surgical unit according to the surgeon preference\n* Allow clear liquids until 2 hours before surgery.\n* Give maltodextrin 2 hours prior to surgery.\n* Prescribe antibiotic prophylaxis if needed.\n* Prescribe post-op anti-nausea\u002Fvomiting medication.\n* Intraoperative management according to Surgeon and Anesthesiologist\n\nPost-operative assessment:\n\n* Apply personalized DVT prophylaxis.\n* Allow food and water shortly after surgery.\n* Encourage mobilization according to the intraoperative managment.\n* Use telemedicine for first follow-ups and later as needed.\n* Scheduled Time Frame pain (NRS scale) and quality of life (PSQ-18, SF-36, QoL, Breast-Q, TSQ-WT) assessment\n* Check for complications 30 days after surgery.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"PROCEDURE","Green Breast Surgery Protocol","A perioperative protocol aiming at reducing environmental impact of surgery, and fast recovery protocol to reduce hospitalization.",[9],[26,29],{"name":27,"affiliation":5,"role":28},"Gianluca Vanni, PhD","PRINCIPAL_INVESTIGATOR",{"name":30,"affiliation":5,"role":31},"Oreste Claudio Buonomo, Full Prof","STUDY_CHAIR",[33,38],{"name":30,"role":34,"phone":35,"phoneExt":36,"email":37},"CONTACT","3395685883","0039","marco.materazzo@ptvonline.it",{"name":39,"role":34,"phone":35,"phoneExt":36,"email":37},"Marco Materazzo, PhD Fellow",[41],{"facility":42,"status":43,"city":44,"state":18,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Università degli Studi di Roma Tor Vergata","RECRUITING","Roma","00133","Italy","IT",{"type":49,"coordinates":50},"Point",[51,52],11.10642,44.99364,{"lat":52,"lon":51},[55,59,61,62,64],{"name":56,"role":34,"phone":57,"phoneExt":18,"email":58},"Oreste Claudio Buonomo, Full Professor","06209088350","o.buonomo@inwind.it",{"name":60,"role":34,"phone":35,"phoneExt":18,"email":37},"Marco Materazzo, MD",{"name":56,"role":28,"phone":18,"phoneExt":18,"email":18},{"name":60,"role":63,"phone":18,"phoneExt":18,"email":18},"SUB_INVESTIGATOR",{"name":65,"role":63,"phone":18,"phoneExt":18,"email":18},"Marco Pellicciaro, MD",{"type":28,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Gianluca Vanni","Principal Investigator","100564111","assessment-of-oncological-safety-quality-of-life-and-environmental-impact-of-the-green-breast-surgery-protocol-100564111",false,"NCT06624917","Assessment of Oncological Safety, Quality of Life, and Environmental Impact of the Green Breast Surgery Protocol","BuGs","Inclusion Criteria:\n\n* Patients candidates for Breast Conserving Treatment\n* ASA score I-II\n* Availability to Telehealth assessment in the postoperative period\n\nExclusion Criteria:\n\n* Drug addiction\n* contraindication for locoregional ultrasound-guided procedure (e.g., local infection, allergy to LA)\n* chronic pain under treatment\n* pregnancy\n* No follow-up planned in our facility","FEMALE","18 Years","75 Years",{"count":80,"type":81},110,"ESTIMATED","INTERVENTIONAL",[84],"NA","Breast Cancer (BC) is the primary oncological diagnosis in women, with the annual incidence expected to exceed 3 million new cases by 2040 due to population growth and aging. During the COVID-19 pandemic, novel methods were adopted worldwide to provide continuous patient care, including telehealth, fast-track protocols such as awake surgery in breast cancer.\n\nThese innovative techniques allowed for improved access to care, and additionally reduced emissions with environmental impact, better resource utilization, and improved continuity of care, but their impact post-pandemic era has not been investigated.\n\nA current issue is the environmental impact of hospitals, particularly operating rooms, as it has been analysed that 25-30% of hospital waste comes from these areas.\n\nA Breast Green Surgery protocol (BuGS protocol) has been designed to reduce Breast Surgery Impact of care, evaluating for the synergistic effect of different procedure for the first time on classic Clincal Outcome, Patients' Reported Outcome Measure (PROM), and Environment Related Outcome Measure (EROM) in breast cancer surgery.\n\nMain hypothesis is that BuGs protocol will provide a significant reduction in carbon footprint of care (EROM) without impacting clinical outcome and PROMs.",[87,88,89],"Breast Cancer Female","Breast Cancer","Breast Neoplasms",[91,92,93],"Breast Neoplasm","Environment Related Outcome Measure","Patients' Reported Outcome Measure","2024-09-30",{"date":96,"type":97},"2024-10-03","ACTUAL",{"date":99,"type":97},"2024-07-01",{"date":101,"type":81},"2025-01-01",{"name":5,"class":6},1]