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NCT07850154Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 30 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
374 (estimated)
First submitted
19 Sept 2026
Start date
1 Oct 2026
Primary completion date
1 Oct 2027
Lead sponsor
Guangzhou Women and Children's Medical Center
NCT number
NCT07850154

What you commit to

  • Study type: Interventional
  • Planned participants: 374
  • From 1 Oct 2026 to the primary completion date, 1 Oct 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Inflammatory breast cancer;
  • Patients with poor general condition who are unable to tolerate surgery.

Other

  • Tumor invasion of the nipple-areola complex, skin, or chest wall;

Who the study is looking for

  • 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.

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Guangzhou Women and Children's Medical Center, Guangzhou Medical University
Coordinator of this site? Confirm its status
GuangzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.