Endoscopic and robotic nipple-sparing mastectomy with immediate breast reconstruction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study focuses on evaluating the safety and aesthetic outcomes of endoscopic and robotic nipple-sparing mastectomy (NSM) combined with immediate prosthesis breast reconstruction for patients with early-stage breast cancer. It aims to gather large-scale prospective data to support the effectiveness of this surgical approach, which is designed to minimize physical and psychological trauma associated with breast cancer surgery. Patients will be monitored postoperatively and asked to complete Patient Reported Outcome Measures (PROMs) questionnaires to assess their satisfaction and recovery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Underwent surgical treatment at Peking University People's Hospital, with hospitalization records;
2. Preoperative core needle biopsy confirmed breast cancer;
3. The clinical stage of the tumor is stage 0-IIIB; 4）cT≤5cm， cN0/cN1，M0， And there is no tumor invasion of the nipple areola complex, skin, and chest wall;

5\) Intraoperative plan to use non biological patches (such as TiLoop) to partially or completely wrap the prosthesis 6) Signed agreement to participate in this study; 7) Can cooperate to complete the Patient Reported Outcome Measures (PROMs) questionnaire.

Exclusion Criteria:

1. Lack of clinical pathological data (such as imaging data, pathological data);
2. Pregnancy or lactation period;
3. Patients with metastatic breast cancer or bilateral breast cancer;
4. Have undergone breast conserving surgery/chest radiation therapy before;
5. Patients with nipple areola invasion and subsequent removal of nipple areola complex;
6. Failed to undergo curative surgery;

Where it's running

• Peking University People's Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: yuan peng, doctor
• Email: 13671287670@163.com
• Phone: 86+13671287670

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.