[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diep-flap-breast-reconstruction\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diep-flap-breast-reconstruction":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,68],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100610665","evaluation-of-wellbeing-and-patient-reported-outcomes-after-open-vs-robotic-mastectomy-with-diep-reconstruction-100610665",false,"NCT07230535","Evaluation of Wellbeing and Patient Reported Outcomes After Open vs Robotic Mastectomy With DIEP Reconstruction","A Randomised Control Trial Evaluating Well Being and Patient Reported Outcomes After Open vs Robotic Single-port Nipple Sparing Mastectomy With DIEP Reconstruction","REBORN","Inclusion Criteria:\n\n* Women aged 18 years and older\n* Candidates who have already been selected to undergo mastectomy (of any kind) and immediate DIEP reconstruction by the breast MDT for the following indications:\n\n  1. Genetic mutation carriers undergoing risk-reducing mastectomy.\n  2. Ductal carcinoma in situ (DCIS) requiring mastectomy.\n  3. Early invasive breast cancer requiring mastectomy.\n  4. For those considered for Nipple Sparing Mastectomy randomisation arms the tumour must not have skin involvement and no evidence of invasive disease within 1cm of skin, nipple or Pec major muscle (as proven on MRI).\n* Candidates for immediate breast reconstruction with DIEP reconstruction\n* Fluent in English\n* Fit for general anaesthetic\n* Signed informed consent form\n\nExclusion Criteria:\n\n* Advanced breast cancer with skin involvement for Nipple Sparing Mastectomy Arms\n* Nipple involvement for Nipple Sparing Mastectomy Arms.\n* Prior chest wall radiation therapy\n* Pregnancy\n* Lactation\n* Patients with insufficient English to sign an informed consent (i.e. interpreter required).","FEMALE","18 Years",{"count":20,"type":21},250,"ESTIMATED","INTERVENTIONAL",[24],"NA","Nipple-sparing mastectomy (NSM) preserves the nipple-areolar complex (NAC) and is associated with improved cosmetic outcomes, body image, and patient satisfaction compared with more ablative techniques. Its use has expanded in both therapeutic and risk-reducing settings, including ductal carcinoma in situ (DCIS) and early-stage invasive breast cancer, where the NAC is not clinically or radiologically involved. Multiple observational and cohort studies support the oncological safety of NSM in appropriately selected patients, provided meticulous surgical technique and pathological assessment are employed to minimise the risk of residual disease.\n\nRobotic-assisted NSM has emerged as a minimally invasive alternative to conventional open techniques. Robotic platforms offer enhanced three-dimensional visualisation, improved instrument articulation, and ergonomic advantages that may facilitate precise dissection while reducing surgeon fatigue. Single-port robotic systems enable NSM to be performed through a single axillary incision, potentially reducing visible scarring and postoperative discomfort while maintaining oncological principles. Early series from high-volume centres have demonstrated the technical feasibility and short-term safety of robotic NSM, with outcomes broadly comparable to open NSM and signals of potential aesthetic benefit. However, these data are largely non-randomised and derived from single-centre experiences.\n\nDespite the increasing adoption of both conventional and robotic NSM, there remains a paucity of high-quality prospective evidence evaluating patient-reported outcomes (PROs). Validated instruments such as the Breast-Q, Hopwood Body Image Scale, and Aesthetic Item Scale (AIS) provide robust measures of patient satisfaction, psychosocial well-being, and aesthetic outcome, yet randomised comparisons of robotic versus open NSM using these tools are lacking. In particular, there is limited evidence examining whether the proposed cosmetic and experiential advantages of robotic surgery translate into meaningful improvements in PROs across different reconstructive pathways.\n\nBreast reconstruction is a critical determinant of postoperative quality of life following mastectomy. Both implant-based reconstruction and autologous reconstruction using deep inferior epigastric perforator (DIEP) flaps are established techniques, each with distinct risk profiles, recovery trajectories, and long-term outcomes. Autologous DIEP reconstruction is associated with superior long-term satisfaction and physical well-being in many patients, while implant-based reconstruction remains the most commonly performed approach nationally. Evaluating NSM techniques across both reconstructive modalities enhances the generalisability and clinical relevance of trial findings.\n\nThe REBORN Network Trial is a multicentre, randomised controlled study conducted within an Irish cancer network using a hub-and-spoke model for robotic surgery delivery. Patients undergoing mastectomy with immediate reconstruction are stratified by reconstruction type (implant-based or DIEP flap) and randomised to receive either robotic-assisted or conventional open NSM. Robotic procedures are centralised within a designated surgical hub, while open procedures are delivered either locally or centrally, depending on reconstructive requirements. This design enables equitable access to robotic surgery while maintaining oncological safety and surgical expertise.\n\nBy comparing robotic-assisted and open NSM within both implant and DIEP reconstruction cohorts using validated PRO measures, this study aims to determine whether robotic technology confers measurable benefits in patient satisfaction, body image, and aesthetic outcome. The findings will inform patient counselling, surgical decision-making, and future service development within networked breast cancer care systems.",[27,28,29,30],"Breast Cancer, Breast Neoplasms","Breast Reconstruction","DIEP Flap Breast Reconstruction","Robotic Surgery","RECRUITING","2026-05-28",{"date":34,"type":35},"2026-06-01","ACTUAL",{"date":37,"type":35},"2025-12-01",{"date":39,"type":21},"2029-12-31",{"name":41,"class":42},"Beaumont Hospital","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":43},"100610048","feasibility-and-safety-of-single-port-robotic-assisted-deep-inferior-epigastric-pedicle-flap-harvest-100610048","NCT07222514","Feasibility and Safety of Single-Port Robotic-Assisted Deep Inferior Epigastric Pedicle Flap Harvest","Feasibility and Safety of Single-Port Robotic-Assisted DIEP Flap Harvest for Breast Reconstruction: A Prospective Evaluation","(DIEP)","Inclusion Criteria:\n\n* Female patients aged ≥18 years.\n* Candidates for unilateral or bilateral breast reconstruction using a DIEP flap.\n* No contraindications for general anesthesia or robotic surgery.\n* Patients with adequate abdominal donor tissue for DIEP flap harvest.\n\nExclusion Criteria:\n\n* History of prior abdominal surgery that significantly compromises perforator vessel integrity.\n* Pregnant woman.\n* Prisoners.\n* BMI \\> 35, as measured during the preoperative evaluation.\n* Presence of comorbidities that contraindicate elective surgery.\n* Active cancer other than breast cancer at the time of evaluation.\n* Active metastatic disease confirmed via imaging or biopsy.\n* Inability to comply with follow-up visits.\n* The research team decides to exclude the patient.",{"count":53,"type":21},4,[24],"The primary aim of this study is to evaluate the feasibility of single-port robotic surgery for DIEP flap breast reconstruction. The investigators will also investigate complications of the procedure, incision length, flap success rate, post operative pain, vascular pedicle length and caliber, and VMP-B score (quality of life\u002Fsatisfaction of breast procedures survey).",[29],[58,30,28],"DIEP flap breast reconstruction","2026-05-23",{"date":61,"type":35},"2026-05-27",{"date":63,"type":35},"2026-05-20",{"date":65,"type":21},"2028-12",{"name":67,"class":42},"Vanderbilt University Medical Center",{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":76,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":80,"conditions":81,"keywords":85,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":43},"100587591","improvement-in-breast-skin-sensibility-after-breast-reconstruction-a-comparison-of-3-surgical-techniques-100587591","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","80 Years",{"count":78,"type":21},63,[24],"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.",[82,83,84,29],"Breast Cancer Surgery","Reconstruction Breast Surgery","Sensitization",[86,87,88,89,90,91,92,93],"free flap","breast reconstruction","autologous-based reconstruction","neurotization","sensory recovery","post-mastectomy sensation","autologous breast reconstruction","DIEP flap","2025-04-08",{"date":96,"type":35},"2025-04-16",{"date":98,"type":21},"2025-04",{"date":100,"type":21},"2029-02",{"name":102,"class":42},"Patricia Esther Engels"]