Application of Single-Port Robot-Assisted Breast-Conserving Surgery Via Axillary Approach for Breast Cancer.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: robot-surgery, traditional open surgry.
- Who it may be relevant to
- Registry conditions: Invasive Breast Carcinoma. Basic parameters: 18 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Procedure robot-surgery
Breast-conserving surgery for breast cancer using single-port robotic surgery. - Procedure traditional open surgry
Breast-conserving surgery for breast cancer using traditional open surgery.
Primary outcome measures
- The successful rate of breast-conserving surgery [Time frame: From enrollment to the end of treatment at 2 weeks]
Secondary outcome measures (1)
- Post-surgery Quality of Life [Time frame: Post-suegery in 1 week, 1month,3months,6months,12moths,24months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Aramy medical center. — Chongqing
- Army Medical Center — Chongqing
Publications
- Yu F, Zhang G, Guo L, Luo F, Chen Y, Xu Y. Single-Port Robotic-assisted Transaxillary Breast-conserving Surgery: A Prospective, Single-arm, Non-randomized Phase IIa Clinical Trial. J Vis Exp. 2025 Aug 19;(222). doi: 10.3791/68459. PMID 40920680
Identifiers
NCT: NCT06738654 · AMCIIT241104