[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616643":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":59,"collaborators":26,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":26,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":26,"enrollmentInfo":71,"targetDuration":26,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":85,"overallStatus":90,"whyStopped":26,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Fakultas Kedokteran Universitas Indonesia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Non-Neurotized Group","ACTIVE_COMPARATOR","Participants assigned to this arm are women undergoing mastectomy who are eligible for standard autologous breast reconstruction without neurotization.",[13],"Procedure: Autologous Breast Reconstruction without Neurotization",{"label":15,"type":16,"description":17,"interventionNames":18},"Neurotized Group","EXPERIMENTAL","Participants assigned to this arm are women undergoing mastectomy who are eligible for autologous breast reconstruction with planned direct neurotization using fully autologous components.",[19],"Procedure: Autologous Breast Reconstruction With Direct Neurotization",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Autologous Breast Reconstruction With Direct Neurotization","The direct neurotization using fully autologous components procedures include:\n\n1. Direct neurotization is carried out using fully autologous components, involving coaptation of the recipient nerve to an autologous nerve graft placed within the flap to facilitate reinnervation.\n2. Surgical breast reconstruction is then completed using patient's own tissue",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Autologous Breast Reconstruction without Neurotization","Breast reconstruction is performed using autologous tissue without nerve coaptation or neurotization, according to standard surgical practice.",[9],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Mohamad Rachadian Ramadan, MD., MRBS.","CONTACT","+62881082855557","rachadian@ui.ac.id",[38],{"facility":39,"status":26,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"dr. Ciptomangunkusumo National Hospital - Faculty of Medicine Universitas Indonesia","Jakarta Pusat","Jakarta Special Capital Region","10430","Indonesia","ID",{"type":46,"coordinates":47},"Point",[48,49],106.8223,-6.1818,{"lat":49,"lon":48},[52,56],{"name":53,"role":34,"phone":54,"phoneExt":26,"email":55},"Ayu PB Sarena, MD, MPH","+6285121316121","ayusarena16@gmail.com",{"name":57,"role":58,"phone":26,"phoneExt":26,"email":26},"Mohamad Rachadian Ramadan, MD, MRBS","PRINCIPAL_INVESTIGATOR",{"type":58,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Mohamad Rachadian Ramadan","dr. Mohamad Rachadian Ramadan, B.Med.Sc, Sp.B.P.R.E, Subsp.M.O.(K), MRBS","100616643","longitudinal-evaluation-of-direct-neurotization-technique-in-breast-reconstruction-with-fully-autologous-components-100616643",false,"NCT07308275","Longitudinal Evaluation of Direct Neurotization Technique in Breast Reconstruction With Fully Autologous Components","Longitudinal Evaluation of Direct Neurotization Technique in Breast Reconstruction With Fully Autologous Components: An Assessment of BREAST-Q Sensation Module, Cutaneous Pressure Threshold, Neuregulin 1 (NRG1) Expression, Nerve Fiber Cross-sectional Area, Intraepidermal Nerve Fiber Density (IENFD), and Breast Morphometry","Inclusion Criteria:\n\n* Female patients aged ≥18 years.\n* Patients with unilateral breast cancer who have undergone or will undergo unilateral mastectomy.\n* Patients undergoing breast reconstruction.\n* Patients with unilateral breast cancer regardless of adjuvant therapy status (receiving radiotherapy and\u002For chemotherapy or receiving no adjuvant therapy).\n* Willing to comply with all scheduled examinations and tissue sampling procedures.\n* Able and willing to provide written informed consent.\n\nExclusion Criteria:\n\n* History of peripheral neuropathy (e.g., diabetes mellitus with neuropathic complications).\n* Bilateral mastectomy.\n* Presence of skin or soft-tissue conditions of the breast that may interfere with sensory assessment.\n* Active smokers (use of tobacco, vape, or other nicotine products within 14 days prior to neurotization).\n* Refusal or inability to attend follow-up evaluations.","FEMALE","18 Years",{"count":72,"type":73},28,"ESTIMATED","INTERVENTIONAL",[76],"NA","This clinical trial aims to evaluate whether direct neurotization using fully autologous components during autologous breast reconstruction improves postoperative breast sensation and sensory-related quality of life in women undergoing unilateral mastectomy. Direct neurotization involves coapting the recipient intercostal nerve to an autologous nerve graft placed within the flap to facilitate reinnervation.\n\nThe study's primary questions are:\n\n1. Does direct neurotization using fully autologous nerve grafts improve cutaneous sensory recovery, as assessed by Semmes-Weinstein monofilament thresholds measured at standardized breast locations?\n2. Does neurotization enhance patient-reported sensory outcomes and quality of life, as assessed by the BREAST-Q Sensation Module?\n\nAs secondary objectives, the study will assess whether biological predictors of nerve regeneration correlate with sensory outcomes. These include:\n\n1. Neuregulin-1 (NRG1) expression in flap tissue biopsy;\n2. Cross-sectional area of the recipient nerve fibres;\n3. Breast morphometry measured at baseline and follow-up;\n4. Intraepidermal nerve fibre density (IENFD) on skin biopsy.\n\nParticipants will be randomly assigned to receive either:\n\n1. Neurotized autologous breast reconstruction using fully autologous graft components, or\n2. Standard (non-neurotized) autologous breast reconstruction.\n\nThe study will compare these groups to determine whether neurotization accelerates or enhances the return of breast sensation over a 6-month follow-up period, with evaluations at 1 month, 3 months, and 6 months after surgery.\n\nParticipants will undergo:\n\n1. Autologous breast reconstruction with or without direct neurotization as part of their planned cancer surgery.\n2. Sensory testing using Semmes-Weinstein monofilaments at baseline, 1, 3, and 6 months.\n3. Completion of BREAST-Q questionnaires evaluating breast sensation, symptoms, and quality of life at each follow-up visit.\n\n3\\. Intraoperative tissue sampling for NRG1 analysis and nerve morphometry. 4. Skin biopsy (if applicable) to assess intraepidermal nerve fibre density. 5. Breast morphometry assessment using a breast morphometry measurement software tool.\n\nThis study seeks to provide high-quality evidence on the effectiveness of direct neurotization using fully autologous components in restoring breast sensation and to explore biological predictors that may influence sensory recovery after autologous breast reconstruction.",[79,80,81,82,83,84],"Breast Reconstruction After Mastectomy","Neurotization","Mastectomy and Breast Reconstruction","Peripheral Nerve Regeneration","Sensory Function","Quality of Life (QOL)",[86,87,88,89],"breast neurotization","mastectomy","breast sensory","quality of life","NOT_YET_RECRUITING","2025-12-15",{"date":93,"type":94},"2025-12-29","ACTUAL",{"date":91,"type":73},{"date":97,"type":73},"2027-04-15",{"name":5,"class":6},1]