Single-Port Robotic-assisted Transaxillary Breast-conserving Surgery: A Prospective, Single-arm, Non-randomized Phase IIa Clinical Trial.
Fan Yu, Gang Zhang, Lingji Guo...
https://pubmed.ncbi.nlm.nih.gov/40920680Actively Recruiting
Phase Not Applicable
Age: 18Years - 65Years
FEMALE
ID06738654
Application of Single-Port Robot-Assisted Breast-Conserving Surgery Via Axillary Approach for Breast Cancer
Led by Xu Yan · Updated on 2026-06-02
64
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, feasibility, and quality of life outcomes for single-port robotic surgery compared to traditional open surgery in breast-conserving surgery for breast cancer. The study aims to compare complications, postoperative recovery, and safety to identify a more effective and safer surgical method for early-stage invasive breast carcinoma. Participants who meet the inclusion criteria will join either the single-port robotic surgery group or the open surgery group based on financial considerations and equipment availability. The study involves two surgical procedures: breast-conserving surgery using either single-port robotic assistance or traditional open surgery. Before surgery, patients undergo imaging tests like mammography, breast ultrasound, and enhanced MRI to collect disease information. During surgery, data such as operating time, blood loss, and intraoperative complications are recorded. Postoperative periods include monitoring complications, pain scores, pathological biopsy results, and hospital stay length. Follow-ups occur at 28 and 90 days to assess complications and mortality rates, with a 3-year follow-up to evaluate disease-free survival and overall survival. Participants will complete quality of life and psychosocial satisfaction questionnaires at multiple time points up to 36 months after surgery. The primary outcome is the success rate of breast-conserving surgery measured up to 2 weeks post-treatment. Secondary outcomes include quality of life assessments at 1 week, 1, 3, 6, 12, and 24 months after surgery. This study does not use randomization or masking and monitors patients closely through hospital stays and follow-up visits to evaluate safety and recovery.
CONDITIONS
Brief Title
Application of Single-Port Robot-Assisted Breast-Conserving Surgery Via Axillary Approach for Breast Cancer.
Who Can Participate
Age: 18Years - 65Years
FEMALE
Eligibility Criteria
You may qualify if you...
- The patient has very high aesthetic requirements and requires no scar on the chest
- No prior chest surgery or radiotherapy
- No contraindications to surgery and anesthesia
- Clinical stage I early breast cancer with appropriate breast volume to maintain good breast shape after surgery
- Meets criteria for breast conservation surgery after preoperative treatment
- Age between 18 and 65 years old
You will not qualify if you...
- Inflammatory breast cancer
- Extensive tumor making negative margins or ideal breast-conserving appearance difficult
- Diffusely distributed malignant calcifications
- Positive surgical margins after extensive tumor resection that cannot be corrected with re-resection
- Patient refuses to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Hospital stay from preoperative admission until discharge after surgery
Participants undergo breast-conserving surgery using either single-port robotic surgery or traditional open surgery. Surgery includes preoperative hospitalization, the operation day, and the postoperative hospitalization period where surgical outcomes and complications are recorded.
1 surgical hospitalization period
Post-operative Follow-up
Duration - 90 days after surgery
Participants are monitored for complications and recovery, including assessments at 28 days and 90 days after surgery to understand complication rates and mortality.
Visits at 28 days and 90 days post-surgery
Long-term Monitoring
Duration - Up to 3 years after surgery
Participants complete quality of life and psychosocial satisfaction assessments at multiple time points up to 3 years after surgery, and disease-free and overall survival are tracked.
Questionnaire visits at 1 week, 1 month, 3 months, 6 months, 12 months, 24 months, and 36 months post-surgery
Trial Site Locations
Total: 2 locations
1
Aramy medical center.
Chongqing, Chongqing Municipality, China, 400042
Not Yet Recruiting
2
Army Medical Center
Chongqing, Chongqing Municipality, China
Actively Recruiting
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Research Team
Y
yan xu Xu, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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