[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640698":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":34,"responsibleParty":48,"collaborators":52,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":24,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":87,"whyStopped":24,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"West China Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"DEDTI group","EXPERIMENTAL","Delayed endoscopic direct-to-implant breast reconstruction",[13],"Procedure: Delayed endoscopic direct-to-implant breast reconstruction",{"label":15,"type":10,"description":16,"interventionNames":17},"T\u002FE group","Two-stage expander-to-implant breast reconstruction",[18],"Procedure: Two-stage expander-to-implant breast reconstruction",[20,25],{"type":21,"name":11,"description":22,"armGroupLabels":23,"otherNames":24},"PROCEDURE","This technique allows for breast reconstruction in a single operation. Taking dual-plane breast reconstruction as an example, preoperative marking lines are drawn to indicate the contour and inframammary fold of the reconstructed breast. A 4-5 cm axillary incision is placed one finger-breadth below the axillary apex. After making the skin incision, the plane between the pectoralis major and minor muscles is identified and dissected, extending approximately 2 cm below the previous mastectomy horizontal scar. The inner and lower parts of the pectoralis major muscle were then separated. Proceed to the subcutaneous layer and continue to dissociate the flap until it reaches the pre-designed folds and the breast boundary. The use of the TiLOOP® Bra depends on the thickness of the patient's flap. Finally, the prosthesis is placed behind the pectoralis major muscle for breast reconstruction.",[9],null,{"type":21,"name":16,"description":26,"armGroupLabels":27,"otherNames":24},"The two-stage expander-to-implant breast reconstruction involves initially placing a tissue expander to stretch the skin. Once the skin has sufficient capacity, a second surgery is performed to replace the expander with a breast implant. The expander can be gradually adjusted based on the patient's skin expansion progress, physical recovery, and aesthetic needs to achieve optimal reconstruction results.",[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":24,"email":33},"Zhenggui Du","CONTACT","+86 13880768222","docduzg@163.com",[35],{"facility":36,"status":24,"city":37,"state":24,"zip":24,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"West China hospital of Sichuan University","Chengdu","China","CN",{"type":41,"coordinates":42},"Point",[43,44],104.06667,30.66667,{"lat":44,"lon":43},[47],{"name":30,"role":31,"phone":32,"phoneExt":24,"email":33},{"type":49,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Du Zhenggui","deputy director",[53,55,57,59,61],{"name":54,"class":6},"West China Second University Hospital",{"name":56,"class":6},"Fourth People's Hospital of Sichuan Province",{"name":58,"class":6},"West China Fourth Hospital",{"name":60,"class":6},"The Second People's Hospital of Chengdu",{"name":62,"class":6},"Suzhou Municipal Hospital","100640698","phase-3-the-comparison-between-dedti-br-and-te-br-100640698",false,"NCT07593846","The Comparison Between DEDTI BR and T\u002FE BR","A National Multicenter, Prospective, Cohort Study Comparing Delayed Endoscopic Direct-to-Implant Breast Reconstruction Via Axillary Approach With the Two-Stage Expander-to-Implant Breast Reconstruction Following Simple Mastectomy","DETE-BR","Inclusion Criteria:\n\n* Female patients aged 18-70 years (inclusive) who have undergone simple mastectomy for breast cancer;\n* At least 1 year after simple mastectomy or 6 months after completion of radiotherapy, with good local skin viability and skin laxity;\n* Voluntary provision of informed consent.\n\nExclusion Criteria:\n\n* Local\u002Fregional recurrence or uncontrolled distant metastasis detected upon re-examination (clinical, imaging, or pathological evidence);\n* Pectoralis major muscle was resected during the initial surgery;\n* Preoperative severe comorbidities with poor general condition, rendering the patient unable to tolerate surgery;\n* Immunodeficiency;\n* Long-term smoking history or poorly controlled diabetes mellitus;\n* Currently participating in other clinical trials that may affect the results of this study.","FEMALE","18 Years","70 Years",{"count":75,"type":76},412,"ESTIMATED","INTERVENTIONAL",[79],"PHASE3","This is a national multicenter, prospective, cohort study. The study aims to compare surgical safety (e.g., surgical complication rates), surgery-related indicators (e.g., operation time, number of operations, surgery-related costs, contralateral breast adjustment operation rates), aesthetic outcomes (e.g., BREAST-Q scores, Harris scores, SCAR-Q scores, Ueda scores and QLQ-BR45 scores), and divorce rate between patients undergoing delayed endoscopic direct-to-implant breast reconstruction via an axillary approach and those undergoing the two-stage expander-to-implant breast reconstruction following simple mastectomy.",[82],"Breast Cancer",[82,84,85,86],"Endoscopic surgery","Minimal invasive surgery","Breast Reconstruction","NOT_YET_RECRUITING","2026-05-11",{"date":90,"type":91},"2026-05-18","ACTUAL",{"date":93,"type":76},"2026-05-01",{"date":95,"type":76},"2028-12-31",{"name":5,"class":6},1]