About this trial
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;
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
robot-surgery
Procedure/SurgeryBreast-conserving surgery for breast cancer using single-port robotic surgery.
traditional open surgry
Procedure/SurgeryBreast-conserving surgery for breast cancer using traditional open surgery.
Treatment groups
Trial outcomes
Primary outcomes
The successful rate of breast-conserving surgery
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 outcomes
Post-surgery Quality of Life
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Xu Yan
Lead sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor institution