Application of Single-Port Robot-Assisted Breast-Conserving Surgery Via Axillary Approach for Breast Cancer.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Invasive Breast Carcinoma
- Sponsor
- Xu Yan
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- The successful rate of breast-conserving surgery
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
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;
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).
Investigators
Xu Yan
Yan Xu,MD., PhD. Department of Breast and Thyroid Surgery Daping Hospital, Army Medical University
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Eligibility Criteria
Inclusion Criteria
- •The patient himself has very high requirements for beauty, and requires no scar on the chest;
- •No chest surgery and radiotherapy.
- •No contraindications to surgery and anesthesia.
- •Clinical I, stage of early breast cancer and the breast has an appropriate volume, can maintain a good breast shape after surgery.
- •Patients in the clinical period who meet the standard of breast conservation surgery after preoperative treatment.
- •Age: 18 and 65 years old.
Exclusion Criteria
- •Inflammatory breast cancer.
- •The tumor is extensive and it's difficult to achieve negative margins or an ideal breast - conserving appearance.
- •Diffusely distributed malignant - characteristic calcifications.
- •The margin is positive after local extensive tumor resection, and a negative margin in pathological examination still can't be ensured after re - resection.
- •The patient refuses.
Outcomes
Primary Outcomes
The successful rate of breast-conserving surgery
Time Frame: 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.