[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611226":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":35,"responsibleParty":52,"collaborators":56,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":100,"sex":106,"minAge":107,"maxAge":108,"enrollmentInfo":109,"targetDuration":18,"studyType":112,"phases":113,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":122,"whyStopped":18,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"West China Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group","EXPERIMENTAL","Remove drainage tubes on postoperative day 5",[13],"Procedure: Drain Removal Timing After Endoscopic Breast Reconstruction Surgery",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","NO_INTERVENTION","Remove drainage tubes when the daily drainage volume is less than 30 ml\u002Fday for two consecutive days after surgery.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"PROCEDURE","Drain Removal Timing After Endoscopic Breast Reconstruction Surgery","The optimal timing for earlier or later removal of drainage tubes after endoscopic breast reconstruction surgery.",[9],[26,31],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Zhenggui Du, Dr","CONTACT","+86 13880768222","docduzg@163.com",{"name":32,"role":28,"phone":33,"phoneExt":18,"email":34},"Tianyuan Li","+86 15510183188","Lity0526@163.com",[36],{"facility":37,"status":18,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"West China Hospital, SiChuan University","Chengdu","Sichuan","610041","China","CN",{"type":44,"coordinates":45},"Point",[46,47],104.06667,30.66667,{"lat":47,"lon":46},[50,51],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},{"name":32,"role":28,"phone":33,"phoneExt":18,"email":34},{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"SPONSOR_INVESTIGATOR","Du Zhenggui","Clinical Professor",[57,59,61,64,66,68,70,72,74,76,78,80,82,84,86,88,90,92,94,96],{"name":58,"class":6},"The First Affiliated Hospital of Shanxi Medical University",{"name":60,"class":6},"West China Fourth Hospital",{"name":62,"class":63},"Bethune Hospital of Shanxi Medical University","UNKNOWN",{"name":65,"class":6},"The First Hospital of Jilin University",{"name":67,"class":6},"Shanxi Province Cancer Hospital",{"name":69,"class":6},"Suining Central Hospital",{"name":71,"class":6},"The Second Affiliated Hospital of Kunming Medical University",{"name":73,"class":6},"Zhengzhou Central Hospital",{"name":75,"class":6},"Deyang People's Hospital",{"name":77,"class":6},"Suzhou Municipal Hospital",{"name":79,"class":6},"Chengdu Fifth People's Hospital",{"name":81,"class":6},"Hunan University of Traditional Chinese Medicine",{"name":83,"class":6},"The First Affiliated Hospital of Zhengzhou University",{"name":85,"class":6},"Fourth People's Hospital of Sichuan Province",{"name":87,"class":6},"China-Japan Union Hospital, Jilin University",{"name":89,"class":6},"Guangzhou First People's Hospital",{"name":91,"class":63},"Xinjiang Medical University Affiliated Cancer Hospital",{"name":93,"class":6},"Fujian Medical University Union Hospital",{"name":95,"class":63},"Central Hospital of Taiyuan",{"name":97,"class":6},"West China Tianfu Hospital","100611226","drain-removal-on-postoperative-safety-and-patient-satisfaction-in-r-e-nsm-with-prepectoral-dibr-100611226",false,"NCT07237828","Drain Removal on Postoperative Safety and Patient Satisfaction in R-E-NSM With Prepectoral DIBR","Drainage Removal After Reverse-Sequence Endoscopic Nipple-Sparing Mastectomy With Direct-to-Implant Prepectoral Breast Reconstruction on Postoperative Safety and Patient Satisfaction : A National Multicenter, Open, Randomized Controlled Study","DRAIN","Inclusion Criteria:\n\n* Female patients aged 18-70 years (inclusive);\n* Patients scheduled for unilateral or bilateral reverse-sequence endoscopic nipple-sparing- mastectomy with immediate prepectoral direct-to-implant breast reconstruction, with the option of concurrent contralateral endoscopic breast augmentation;\n* Patients with preoperative pathological confirmation of carcinoma in situ, invasive cancer, or those undergoing prophylactic mastectomy;\n* Patients with a maximum tumor diameter≤5 cm (before\u002Fafter neoadjuvant chemotherapy), and no clinical or radiological evidence of nipple, skin, chest wall invasion, or distant metastasis;\n* BMI \\\u003C 40 kg\u002Fm²;\n* Implant volume \\\u003C 600 mL;\n* Patients who are able and willing to sign the informed consent form.\n\nExclusion Criteria:\n\n* History of breast surgery within 1 year prior to this operation (excluding VABB and biopsy);\n* Tumor invasion of the skin, pectoralis major muscle, chest wall, or nipple-areola complex;\n* Advanced tumor stage (M1);\n* Breast cancer during pregnancy or lactation;\n* Scars below the nipple level and a history of previous radiotherapy;\n* Patients with severe comorbidities before surgery, poorly controlled diabetes, immunodeficiency, or poor general condition that cannot tolerate surgery;\n* HbA1c \\> 7.5%;\n* Active smoking history (≥20 cigarettes per day);\n* Intraoperative flap burns, intraoperative nipple excision; postoperative complications such as infection, flap ischemia, or surgical cavity bleeding within 1-4 days after surgery; or other causes leading to incisions on the surface of the breast; patients who undergo nipple excision within 1 month after surgery should be excluded from the study;\n* Currently participating in other clinical studies that may affect participation in this trial.\n* Refusal to sign the informed consent form.","FEMALE","18 Years","70 Years",{"count":110,"type":111},379,"ESTIMATED","INTERVENTIONAL",[114],"NA","Breast cancer is a malignant tumor that seriously threatens the health of women, with an increasing incidence rate. The current main treatment methods include multidisciplinary diagnosis and treatment such as surgery, radiotherapy, chemotherapy, and endocrine therapy, among which surgery is the key. Postoperative care is also very important. Traditional breast surgery requires long-term placement of drainage tubes after the operation. However, long-term placement of drainage tubes increases the incidence of postoperative complications such as infection and delayed wound healing, prolongs hospital stays, increases economic burden, and also affects the aesthetic outcome. Our team has innovatively adopted the \"reverse-sequence\" endoscopic nipple-sparing-mastectomy with direct-to-implant breast reconstruction. This method is highly efficient and safe, with no incisions on the surface of the breast, reducing the risk of incision dehiscence and the probability of flap ischemia and necrosis. Based on this, our team proposes to appropriately relax the drainage criteria and remove the drainage tube earlier under the premise of ensuring the sterility of the effusion, and preliminary findings show that patients have better postoperative aesthetic outcomes, with a lower incidence of flap infection, ischemia, and necrosis than expected, and the degree of breast deformation caused by radiotherapy is also reduced. However, there is still controversy over the pros and cons of drainage criteria. Some scholars believe that strict drainage criteria can reduce the risk of infection and implant displacement, and plastic surgeons are more concerned about the impact of long-term tube placement on aesthetic outcomes and quality of life. Currently there is a lack of large sample, multicenter, randomized controlled studies to provide high - level evidence. Therefore, our team plans to conduct a national multicenter, open, randomized controlled study to compare the advantages and disadvantages of the two drainage methods under the premise of not reducing postoperative surgical and oncological safety, in order to explore the optimal timing for drain removal and improve patients' satisfaction with the reconstructed breast.",[117],"Breast Cancer",[117,119,120,121],"Minimal invasive surgery","Nipple-sparing mastectomy","Endoscopic surgery","NOT_YET_RECRUITING","2025-11-14",{"date":125,"type":126},"2025-11-20","ACTUAL",{"date":128,"type":111},"2025-12-01",{"date":130,"type":111},"2032-06-30",{"name":54,"class":6},1]