About this trial
Evaluation of the effectiveness and safety of laparoscopic assisted breast resection with preservation of nipple and areola, combined with chest muscle anterior prosthesis and patch for immediate one-step breast reconstruction and concurrent autologous fat transplantation in a prospective study
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women aged 18 to 70 years old;
In the first diagnosis of unilateral breast cancer patients, the maximum diameter of invasive tumor is ≤ 5cm, and there is no requirement for tumor size of carcinoma in situ in principle;
Patients undergoing preventive mastectomy are not allowed to be included in the study;
Clinical examination and auxiliary examinations suggest that the tumor is confined to the mammary gland and has not invaded the nipple areola complex, skin, or chest wall;
Disqualifiers
Specialized physical examination and/or auxiliary examination suggest that the tumor involves the nipple areola complex (including Paget's disease) or the skin;
Double breast cancer;
Bilateral breast reconstruction patients;
Patients who have undergone fat injection, breast augmentation with implants, and breast reduction surgery in the past;
Trial design
Single group
Treatments tested in this trial
Endoscopic assisted NSM+breast reconstruction+simultaneous fat transplantation
Procedure/SurgeryLaparoscopic assisted mastectomy with preservation of nipple and areola, combined with chest muscle anterior prosthesis and patch, immediate one-step breast reconstruction and simultaneous autologous fat transplantation
Treatment groups
Trial outcomes
Primary outcomes
Incidence of serious complications after breast reconstruction surgery
All surgical related complications (including hematoma, poor wound healing, skin flap necrosis, infection, incision dehiscence, fat injection related complications, etc.) are classified according to the Clavien Dindo scoring system. The Clavien Dindo grading system is based on the severity of postoperative complications and whether corresponding treatment is needed for the complications. Postoperative complications are classified into grades I-V, and those classified as grade III or above by Clavien Dindo are considered serious complications.
Secondary outcomes
BREAST-Q (Breast Reconstruction Module) score
This experiment obtained subject report results from four dimensions of breast satisfaction, psychological health, physical health, and sexual health using the BREAST-Q (Breast Reconstruction Module) scoring system. BREAST-Q scoring was performed at preoperative, 1 month, 3 months, 6 months, and 12-month follow-up. The BREAST-Q score at 12 months after surgery is the main evaluation metric.
Success rate of breast reconstruction
Calculation formula:The result of subtracting the number of implant removal cases caused by complications from the total number of breast reconstruction cases received, divided by the total number of reconstruction cases received.Definition of implant removal caused by complications: Refers to the removal of implants during the 12-month follow-up period due to surgical related reasons such as hematoma, serum swelling, skin flap necrosis, nipple areola necrosis, infection, incision dehiscence, implant exposure, capsule contraction, and prosthesis displacement.
All incidence of complications
Complications such as hematoma, poor wound healing, skin flap necrosis, infection, incision dehiscence, and fat injection related complications are classified according to the Clavien Dindo scoring system, including grades I-V, and evaluated and recorded.
Breast cosmetic effects evaluated by doctors
The cosmetic effect of breast reconstruction is evaluated by professional doctors independent of the surgeon using the ueda scoring criteria based on patient photos.
Sponsors and contacts
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