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This is a multicenter, retrospective observational study comparing the safety and efficacy of robotic-assisted versus endoscopic-assisted axillary lymph node dissection (ALND) in patients with node-positive breast cancer. The study aims to evaluate the protective effect on the intercostobrachial nerve (ICBN), perioperative outcomes, postoperative complications, and quality of life between the two minimally invasive techniques, as well as to assess long-term oncological outcomes including axillary recurrence and survival. Data will be extracted from routine clinical records. The study will compare the robotic group and the endoscopic group with respect to the following outcome measures:
This study has been approved by the Research Ethics Committee of Guangzhou Medical University Affiliated Women and Children's Medical Center. A waiver of informed consent has been granted due to the retrospective nature of the study. All patient data will be anonymized and kept confidential. Statistical analyses will be performed using R, SPSS and GraphPad Prism, with a P value < 0.05 considered statistically significant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R-ALND | Participants with breast cancer who underwent robotic-assisted axillary lymph node dissection. | ||
| E-ALND | Participants with breast cancer who underwent endoscopic-assisted axillary lymph node dissection. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Sensory Impairment in Intercostobrachial Nerve Innervated Regions | Sensory function assessed in four key regions innervated by the intercostobrachial nerve (ICBN): medial upper arm, axilla, lateral chest wall, and upper chest wall. Four sensory modalities are evaluated using standardized bedside sensory testing: light touch, pinprick, cold sensation, and warm sensation. The evaluation of sensory impairment includes the following dimensions: (1) type of sensory impairment (e.g., hypoesthesia, hyperesthesia, paresthesia, or anesthesia); (2) location of impairment (specific ICBN-innervated regions affected); (3) extent/area of impairment (measured as the involved surface area within each region); and (4) proportion of impairment (the percentage of patients with sensory impairment in each region and modality). These sensory outcomes are compared between the robotic-assisted and endoscopic-assisted axillary lymph node dissection groups. | At postoperative follow-up assessments (e.g., 1 month, 3 months, 6 months, and 12 months after surgery, with additional long-term follow-up based on data availability) |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Assessed by Cancer Therapy - Breast + 4 | Health-related quality of life is evaluated using the Functional Assessment of Cancer Therapy - Breast + 4 (FACT B+4) questionnaire, which assesses physical, social, emotional, and functional well-being, with additional breast cancer-specific concerns. | At postoperative follow-up visits (1 month, 3 months, 6 months, and 12 months after surgery, with additional long-term follow-up based on data availability) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with breast cancer who underwent either robotic-assisted or endoscopic-assisted axillary lymph node dissection at the Department of Breast and Thyroid Surgery Center, Guangzhou Medical University Affiliated Women and Children's Medical Center and Foshan Fosun Chancheng Hospital.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foshan Fosun Chancheng Hospital | Foshan | Guangdong | China | |||
| Guangzhou Women and Children's Medical Center, Guangzhou Medical University |
Individual participant data will not be shared due to the retrospective nature of this study and concerns regarding patient privacy and confidentiality. The data were extracted from routine clinical records under a waiver of informed consent granted by the ethics committee, and the original consent forms did not include provisions for data sharing with external researchers. Therefore, IPD sharing is not planned. However, summarized data and analytical codes may be available from the corresponding author upon reasonable request, subject to institutional and ethical approval.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 27, 2026 | Jul 3, 2026 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Upper Limb Function Assessed by Disabilities of the Arm, Shoulder and Hand Scores | Upper limb function is assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, which evaluates the ability to perform daily activities and the severity of upper extremity symptoms. Scores are compared between the robotic-assisted and endoscopic-assisted groups. | At postoperative follow-up visits (1 month, 3 months, 6 months, and 12 months after surgery, with additional long-term follow-up based on data availability) |
| Postoperative Complications | The incidence of postoperative complications is compared between the robotic-assisted and endoscopic-assisted groups, including but not limited to: seroma, hematoma, wound infection, surgical site infection, lymphedema of the ipsilateral upper extremity, shoulder dysfunction, and other procedure-related adverse events. All complications are graded according to the Clavien-Dindo classification system. | Within 30 days post-surgery and at long-term follow-up assessments |
| Recurrence and Metastasis Events | The incidence of axillary recurrence, locoregional recurrence, and distant metastasis is compared between the robotic-assisted and endoscopic-assisted ALND groups, with all events confirmed by histopathological or radiological evidence. | Up to 5 years post-surgery, with follow-up duration based on data availability from routine clinical records |
| Survival Outcomes | Disease-free survival (DFS), defined as time from surgery to first recurrence, metastasis, or death, and overall survival (OS), defined as time from surgery to death from any cause, are compared between the two groups. | Up to 5 years post-surgery, with follow-up duration based on data availability from routine clinical records |
| Operative Time | Operative time (minutes) is compared between the robotic-assisted and endoscopic-assisted axillary lymph node dissection groups. | During surgery, recorded in the operative note |
| Intraoperative Blood Loss | Intraoperative Blood Loss(mL) is compared between the robotic-assisted and endoscopic-assisted axillary lymph node dissection groups. | During surgery, recorded in the operative note |
| The number of Lymph Nodes Dissected | The number of lymph nodes dissected is compared between the robotic-assisted and endoscopic-assisted axillary lymph node dissection groups. | During surgery, recorded in the operative note |
| Postoperative Recovery Parameters | Length of hospital stay (days) and duration of postoperative drainage (days) are compared between the robotic-assisted and endoscopic-assisted groups. | During index hospitalization and within 30 days post-surgery |
| Intercostobrachial Nerve Identification and Preservation | The number of intercostobrachial nerve identified, the number of intercostobrachial nerve preserved, and intercostobrachial nerve grading (based on intraoperative anatomical classification) are compared between the robotic-assisted and endoscopic-assisted groups. | During surgery, recorded in the operative note |
| Guangzhou |
| Guangdong |
| 510000 |
| China |
| D017437 |
| Skin and Connective Tissue Diseases |