Subjects who have received or plan to receive unilateral or bilateral nipple sparing mastectomy (NSM) with the SP single-port robot, with or without breast reconstruction.
Conditions
Interventions
Observation group:NA
Sponsors
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (Boao Research Hospital in Hainan)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Female patients who have received or plan to receive nipple sparing mastectomy (NSM) with or without breast reconstruction (prosthesis or autologous tissue implantation) with the SP single-port robot; 2. Patients with a body mass index (BMI) =18 at the time of procedure; 4. Patients with diagnosis of breast cancer with preoperative clinical stage T1-2, N0-1, or patients who plan to undergo prophylactic resection to reduce the risk of breast cancer; 5. Patients with tumor(s) located >= 1 cm from the nipple-areolar complex (NAC) (confirmed by imaging modalities performed, and including but not limited to breast mammography (MMG), magnetic resonance imaging (MRI), ultrasound examination, or physical examination) (for patients with non-prophylactic resection); 6. Patients with breast cup size C or smaller (defined as the difference in chest circumference between the fullest part of the breast and the fold of the breast <= 15.0 cm[1]); 7. Patients with low to moderate risk for anesthesia (American Society of Anesthesiologists (ASA) I, II or III); 8. Patients who voluntarily participate in the study and sign the ICF (or exempt from signature of the ICF as approved by the EC). *The Breast Cancer Staging in AJCC Cancer Staging Manual (Edition 8) is applicable[2].
Exclusion criteria
Exclusion criteria: 1. Patients with known diagnosis of inflammatory breast cancer; 2. Patients with inflammatory and/or infectious skin condition and/or unhealed wounds on the ipsilateral breast; 3. Patients with high risk for anesthesia (ASA>=IV) or existing serious complications (i.e., cardiac, pulmonary and neurologic) that preclude longer anesthesia times; 4. Patients with missing data on the primary endpoints in retrospective cases; 5. Patients determined to be unsuitable for minimally invasive surgery; 6. Other circumstances in which patients are considered inappropriate to participate in this clinical trial by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intraoperative conversion rate;Incidence of device-related or possibly related complications of Clavien-Dindo Grade III or above 1 month after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Positive surgical margin rate;Surgical duration;Intraoperative bleeding volume;Blood transfusion rate;Intraoperative specimen weight;Length of stay (LOS);Unplanned procedure-related readmission rate within 1 month after surgery;Unplanned procedure-related reoperation rate within 1 month after surgery;Short-term recovery of functions;Patient satisfaction;Quality of life ; | — |
Countries
China
Contacts
Public ContactXiaosong Chen;Jiayi Wu
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (Boao Research Hospital in Hainan)
Outcome results
None listed