About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female patients aged 18-70 years (inclusive);
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;
Patients with preoperative pathological confirmation of carcinoma in situ, invasive cancer, or those undergoing prophylactic mastectomy;
Patients with a maximum tumor diameter≤5 cm (before/after neoadjuvant chemotherapy), and no clinical or radiological evidence of nipple, skin, chest wall invasion, or distant metastasis;
Disqualifiers
History of breast surgery within 1 year prior to this operation (excluding VABB and biopsy);
Tumor invasion of the skin, pectoralis major muscle, chest wall, or nipple-areola complex;
Advanced tumor stage (M1);
Breast cancer during pregnancy or lactation;
Trial design
Parallel
Treatments tested in this trial
Drain Removal Timing After Endoscopic Breast Reconstruction Surgery
Procedure/SurgeryThe optimal timing for earlier or later removal of drainage tubes after endoscopic breast reconstruction surgery.
Treatment groups
Trial outcomes
Primary outcomes
Aesthetic outcome evaluation--BREAST-Q scores
The Satisfaction with Breasts module of BREAST-Q questionnaire is utilized to assess patient-reported aesthetic outcomes. Transformed scores range from 0 to 100, with higher scores indicating better outcomes. Both raw questionnaire scores and standardized transformed scores will be documented, along with pre- to postoperative differences in transformed scores
Secondary outcomes
Drainage tube indwelling duration
The duration of drainage tube indwelling refers to the total time from the postoperative insertion of the drainage tube to its removal, measured in days
Quality of Life--EORTC Quality of Life scores
EORTC Scores are a series of questionnaires developed by the European Organisation for Research and Treatment of Cancer (EORTC) to assess the health-related quality of life (HRQoL) of cancer patients. These questionnaires are widely used in clinical trials and clinical practice to help evaluate treatment outcomes and patients' quality of life. The scoring range is from 0 to 100. A higher score in the functional domains indicates better functioning, while a higher score in the symptom domains indicates more severe symptoms.
wound care
The differences in the number of dressing changes and wound care procedures.
Complications
Skin flap thermal injury, skin flap ischemia/necrosis, nipple and areola complex(NAC) ischemia/necrosis, surgical site infection, incision dehiscence, surgical site bleeding or hematoma, seroma needing repeated aspiration or drain reinsertion, capsular contracture, prosthesis outline appearance, rippling, implant displacement, implant loss, readmission
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Du Zhenggui
Lead sponsor
West China Hospital
Sponsor institution
The First Affiliated Hospital of Shanxi Medical University
Collaborator
West China Fourth Hospital
Collaborator
Bethune Hospital of Shanxi Medical University
Collaborator
The First Hospital of Jilin University
Collaborator
Shanxi Province Cancer Hospital
Collaborator
Suining Central Hospital
Collaborator
The Second Affiliated Hospital of Kunming Medical University
Collaborator
Zhengzhou Central Hospital
Collaborator
Deyang People's Hospital
Collaborator
Suzhou Municipal Hospital
Collaborator
Chengdu Fifth People's Hospital
Collaborator
Hunan University of Traditional Chinese Medicine
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
Fourth People's Hospital of Sichuan Province
Collaborator
China-Japan Union Hospital, Jilin University
Collaborator
Guangzhou First People's Hospital
Collaborator
Xinjiang Medical University Affiliated Cancer Hospital
Collaborator
Fujian Medical University Union Hospital
Collaborator
Central Hospital of Taiyuan
Collaborator
West China Tianfu Hospital
Collaborator
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