Impact of Robotic Versus Endoscopic Surgery on Nipple Nerve Function Following Nipple-Sparing Mastectomy for Breast Cancer
A Multicenter, Prospective, Randomized Two-arm Controlled Trial Comparing the Impact of Robotic Versus Endoscopic Surgery on Breast Nerve Function Following Nipple-sparing Mastectomy for Breast Cancer
1 other identifier
interventional
374
1 country
1
Brief Summary
This is a multicenter, prospective, randomized parallel controlled two arm clinical trial, designed to systematically evaluate impact of robotic versus endoscopic surgery on breast nerve function in patients undergoing nipple sparing mastectomy for breast cancer. The study will comprehensively assess the neurological functional outcomes, oncological safety, quality of life and sexual health, perioperative efficacy, surgical complications, and health economic value of the two minimally invasive approaches. This study has been approved by the Institutional Review Board of the Affiliated Women and Children's Medical Center of Guangzhou Medical University. Written informed consent will be obtained from all eligible participants prior to enrollment. All patient data will be anonymized and kept strictly confidential. Statistical analyses will be performed using SPSS 27.0 software, with a P value \< 0.05 set as the threshold for statistical significance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2026
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2026
CompletedFirst Posted
Study publicly available on registry
September 30, 2026
CompletedStudy Start
First participant enrolled
October 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2031
September 30, 2026
September 1, 2026
1 year
September 19, 2026
September 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Tactile pressure sensation of the nipple-areola complex at 6 months postoperatively
Tactile pressure sensation will be measured using Semmes-Weinstein monofilaments. The examiner will apply the device to the nipple-areola complex, using filaments of incrementally increasing force (0.07 g, 0.4 g, 2.0 g, 4.0 g, 300 g), and record the lightest filament detectable by the patient.
12 months postoperatively
Positive surgical margin rate
Intraoperative / postoperative (2 weeks after surgery)
Secondary Outcomes (13)
Tactile pressure sensation of the nipple-areola complex and breast skin at multiple postoperative time points
Baseline, 1 week, 2 weeks, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months postoperatively
Temperature sensation of the nipple-areola complex and breast skin
Baseline, 1 week, 2 weeks, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months postoperatively
Erection function of the nipple-areola complex
Baseline, 1 week, 2 weeks, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months postoperatively
Patient-reported outcomes
Baseline, 1 week, 2 weeks, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months postoperatively
Disease-free survival (DFS)
Following surgery up to 3 years
- +8 more secondary outcomes
Study Arms (2)
Robotic-assisted nipple-sparing mastectomy group
EXPERIMENTALPatients undergo robotic-assisted nipple-sparing mastectomy for breast cancer.
Endoscopic-assisted nipple-sparing subcutaneous mastectomy group
EXPERIMENTALPatients undergo endoscopic-assisted nipple-sparing mastectomy for breast cancer.
Interventions
Robotic-assisted nipple-sparing mastectomy for breast cancer.
Endoscopic-assisted nipple-sparing mastectomy for breast cancer.
Eligibility Criteria
You may qualify if:
- Ductal carcinoma in situ (DCIS), or invasive breast cancer with clinical stage T1-T3, N0-N1 and no distant metastasis;
- Breast size ≤ cup C, without significant breast ptosis;
- Patients with high aesthetic requirements who elect single-incision robotic or endoscopic-assisted nipple-sparing mastectomy;
- Patients eligible for prophylactic mastectomy;
- Patients understand the study protocol and sign the written informed consent form.
You may not qualify if:
- Tumor invasion of the nipple-areola complex, skin, or chest wall;
- Inflammatory breast cancer;
- Patients with poor general condition who are unable to tolerate surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Guangzhou Women and Children's Medical Center, Guangzhou Medical University
Guangzhou, Guangdong, 510000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Physician, Department of Breast Surgery
Study Record Dates
First Submitted
September 19, 2026
First Posted
September 30, 2026
Study Start
October 1, 2026
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
October 1, 2031
Last Updated
September 30, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will not share
Individual participant data will not be shared due to the prospective design of this study and concerns regarding patient privacy and confidentiality. The data are collected in accordance with the study protocol under the approval of the ethics committee, with written informed consent obtained from all enrolled participants, and the original consent forms do 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.