[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587591":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":29,"centralContacts":33,"locations":42,"responsibleParty":70,"collaborators":12,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":76,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":12,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":97,"overallStatus":45,"whyStopped":12,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"University Hospital, Geneva","OTHER",[8,13,19],{"label":9,"type":10,"description":11,"interventionNames":12},"no nerve suture","NO_INTERVENTION","No nerve suture will be carried out.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"direct nerve suture","EXPERIMENTAL","Epineural coaptation of one nerve of the flap to one nerve of the breast region",[18],"Procedure: Nerve Suture",{"label":20,"type":15,"description":21,"interventionNames":22},"interposition of an autograft","Epineural coaptation intercostal nerve flap to autograft (from another intercostal nerve of the flap) to intercostal nerve of the breast = interposition of an autograft",[18],[24],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":12},"PROCEDURE","Nerve Suture","Sensory nerve coaptations will be performed\n\n1. either by suturing the donor to the recipient nerve immediately (1 coaptation)\n2. or by interposing an autograft originating from the zone of the flap to be discarded (2 coaptations). The anterior cutaneous branch (ACB) of the 3rd or 4th intercostal nerve (ICN) will be connected to the sensory branch of the 10th, 11th or 12th ICN of the flap.",[14,20],[30],{"name":31,"affiliation":5,"role":32},"Patricia E Engels, MD","PRINCIPAL_INVESTIGATOR",[34,38],{"name":31,"role":35,"phone":36,"phoneExt":12,"email":37},"CONTACT","+41795537557","patricia.engels@hug.ch",{"name":39,"role":35,"phone":40,"phoneExt":12,"email":41},"Axelle Serre, MD","+41795538642","axelle.serre@usb.ch",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Geneva University Hospitals","RECRUITING","Geneva","Canton of Geneva","1205","Switzerland","CH",{"type":52,"coordinates":53},"Point",[54,55],6.14569,46.20222,{"lat":55,"lon":54},[58,59,61,62,64,66,68],{"name":31,"role":35,"phone":36,"phoneExt":12,"email":37},{"name":39,"role":35,"phone":40,"phoneExt":12,"email":60},"axelle.serre@hug.de",{"name":31,"role":32,"phone":12,"phoneExt":12,"email":12},{"name":39,"role":63,"phone":12,"phoneExt":12,"email":12},"SUB_INVESTIGATOR",{"name":65,"role":63,"phone":12,"phoneExt":12,"email":12},"Stephanie N Schulz, MD",{"name":67,"role":63,"phone":12,"phoneExt":12,"email":12},"Srinivas Madduri, PhD",{"name":69,"role":63,"phone":12,"phoneExt":12,"email":12},"Daniel F Kalbermatten, PhD",{"type":71,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"SPONSOR_INVESTIGATOR","Patricia Esther Engels","Principal Investigator, Consultant and Senior Clinical Researcher","100587591","improvement-in-breast-skin-sensibility-after-breast-reconstruction-a-comparison-of-3-surgical-techniques-100587591",false,"NCT06930378","Improvement in Breast Skin Sensibility After Breast Reconstruction: a Comparison of 3 Surgical Techniques","Sensory Restoration in DIEP Free Flaps for Post-Mastectomy Breast Reconstruction After Breast Cancer: Comparing Non-sensitized Standard Technique to Direct Nerve Suture and to Autograft: A Three-arm, Randomized, Double-blinded Superiority Trial","S-DIEP","A) Pilot study\n\nInclusion criteria:\n\n* 18-80 years old\n* having received DIEP flap breast reconstruction with a flap not completely buried\n* having given written informed consent for participating in the study\n\nExclusion criteria:\n\n* postoperative radiotherapy on the flap\n* neurological conditions as diabetic neuropathy, alcoholism or any other severe underlying peripheral neuropathy including chemotherapy-induced neuropathy or neuropathy induced by other medications\n* active smoking\n* language barrier\n* pregnancy or lactating women\n\nB) Main study\n\nInclusion Criteria:\n\n* 18 to 80 years old\n* having given written informed consent for participating in the study\n* receiving immediate or delayed unilateral DIEP breast reconstruction with a DIEP flap which will not be completely buried\n\nExclusion Criteria:\n\n* autologous reconstruction where the flap is completely buried\n* patients in need of both-sided reconstruction (double DIEP)\n* postoperative radiotherapy on the flap\n* neurological conditions as diabetic neuropathy, alcoholism, or any other severe underlying peripheral neuropathy including chemotherapy-induced neuropathy or neuropathy induced by other medications\n* active smoking\n* language barrier\n* pregnancy at time of planned DIEP flap surgery and lactation","FEMALE","18 Years","80 Years",{"count":86,"type":87},63,"ESTIMATED","INTERVENTIONAL",[90],"NA","The goal of this clinical trial is to learn if nerve sutures in free flap breast reconstruction can optimize sensibility in the reconstructed breast in patients opting for DIEP flap breast reconstruction due to breast cancer or genetic conditions. Affected women 18 to 80 years old can be included. The main question is:\n\nIf a nerve suture was carried out, can pressure be felt better on the reconstructed breast after 12 months? If a nerve suture was carried out, will better sensibility and quality of life be felt and perceived (questionnaire) at 12 and 24 months after the initial operation ? Researchers will compare two different nerve suture techniques and no nerve suture to one another to see if and which nerve suture optimizes sensibility.\n\nParticipants will have regular visits and follow-up controls, during which\n\n* their sensibility will be tested multimodally,\n* they will fill out questionnaires\n* skin biopsies will be taken.",[93,94,95,96],"Breast Cancer Surgery","Reconstruction Breast Surgery","Sensitization","DIEP Flap Breast Reconstruction",[98,99,100,101,102,103,104,105],"free flap","breast reconstruction","autologous-based reconstruction","neurotization","sensory recovery","post-mastectomy sensation","autologous breast reconstruction","DIEP flap","2025-04-08",{"date":108,"type":109},"2025-04-16","ACTUAL",{"date":111,"type":87},"2025-04",{"date":113,"type":87},"2029-02",{"name":72,"class":6},1]