Invasive Breast Carcinoma
Conditions
Brief summary
Evaluate the safety,feasibility and quality of life(QoL)of single-port robotic surgery in breast-conserving surgery, compare and analyze the advantages and disadvantages of single-port robotic surgery and open surgery in terms of complications, postoperative complications, perioperative recovery effects, and safety in breast cancer breast-conserving surgery, in order to select a more effective and safe surgical method. Subjects who meet the inclusion criteria will enter the research process, with surgery including SPr-breast-conserving surgery or open-breast-conserving surgery, and the choice of the two surgical methods is based on the patient's financial situation and the availability of equipment;
Detailed description
Evaluate the safety and feasibility of single-port robotic surgery in breast-conserving surgery, compare and analyze the advantages and disadvantages of single-port robotic surgery and open surgery in terms of complications, postoperative complications, perioperative recovery effects, and safety in breast cancer breast-conserving surgery, in order to select a more effective and safe surgical method. Subjects who meet the inclusion criteria will enter the research process, with surgery including SPr-breast-conserving surgery or open-breast-conserving surgery, and the choice of the two surgical methods is based on the patient's financial situation and the availability of equipment; - Preoperative hospitalization period: Collect patient disease information (including mammography, breast ultrasound, breast enhanced MRI, etc.) - On the day of surgery: Record operating time, intraoperative blood loss, intraoperative complications, intraoperative adverse events, etc.; - Postoperative hospitalization period: Record postoperative complications (postoperative bleeding, necrosis of the flap or nipple-areola complex, subcutaneous emphysema, infection, capsule spasm, postoperative shoulder pain and discomfort, etc.), postoperative pain scores, postoperative pathological biopsy; - Postoperative hospital stay: Calculated from the day of surgery to the day of discharge; - 28 days postoperatively: Understand the complication rate and mortality rate within 28 days postoperatively; - 90 days postoperatively: Understand the complication rate and mortality rate within 90 days postoperatively; - 3-year disease-free survival period (calculated from the time of surgery to the last follow-up or recurrence and metastasis date, recurrence is defined as recurrence in the surgical area and distant metastasis); - 3-year overall survival rate (calculated from the time of surgery to the last follow-up or death). In addition, postoperative quality of life and psychosocial satisfaction were assessed in all patients. Questionnaire surveys for quality of life were conducted at 1 week, 1 month, 3 months, 6 months, 12 months, 24 months and 36 months after surgery.
Interventions
PROCEDURErobot-surgery
Breast-conserving surgery for breast cancer using single-port robotic surgery.
PROCEDUREtraditional open surgry
Breast-conserving surgery for breast cancer using traditional open surgery.
Sponsors
Xu Yan
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Experimental Group: Breast-conserving surgery for breast cancer using single-port robotic surgery. Control Group: Breast-conserving surgery for breast cancer using traditional open surgery.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The patient himself has very high requirements for beauty, and requires no scar on the chest; 2. No chest surgery and radiotherapy. 3. No contraindications to surgery and anesthesia. 4. Clinical I, stage of early breast cancer and the breast has an appropriate volume, can maintain a good breast shape after surgery. 5. Patients in the clinical period who meet the standard of breast conservation surgery after preoperative treatment. 6. Age: ≥18 years old.
Exclusion criteria
1. Inflammatory breast cancer. 2. The tumor is extensive and it's difficult to achieve negative margins or an ideal breast - conserving appearance. 3. Diffusely distributed malignant - characteristic calcifications. 4. The margin is positive after local extensive tumor resection, and a negative margin in pathological examination still can't be ensured after re - resection. 5. The patient refuses.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The successful rate of breast-conserving surgery | From enrollment to the end of treatment at 2 weeks | Whether intraoperative frozen section biopsy of the surgical margins detects cancer cells; if it is negative after two or fewer attempts, then the breast-conserving surgery is considered successful. |
Secondary
| Measure | Time frame |
|---|---|
| Post-surgery Quality of Life | Post-suegery in 1 week, 1month,3months,6months,12moths,24months |
Countries
China
Contacts
CONTACTyan xu Xu, Doctor
Outcome results
None listed