Actively Recruiting

FEMALE
NCT06748677

Endoscopic and Robotic NSM with Immediate Prosthesis Breast Reconstruction

Led by Peking University People's Hospital · Updated on 2025-01-07

484

Participants Needed

1

Research Sites

364 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Breast cancer is the most common malignant tumor in women. Surgical treatment is the most important treatment for early breast cancer. Breast cancer resection is considered to be a destructive operation. Patients need to accept the double blow of physical and psychological loss of breast shape. Although with the change of the concept of early diagnosis and treatment of breast cancer, the breast conserving rate of breast cancer is gradually increasing in China, more than half of the patients are still unable to retain breast due to their condition. For these patients, breast reconstruction surgery is an important means to improve the postoperative breast shape. With the improvement of surgical technology, endoscopic/robotic NSM combined with immediate prosthesis breast reconstruction has been gradually developed. According to previous literature reports, it has good tumor safety and aesthetics, but it is still lack of large-scale prospective results. This project plans to adopt a prospective cohort design, based on the large sample breast disease cohort database established by the breast center of Peking University People's Hospital, and prospectively include patients who receive NSM combined with immediate prosthesis reconstruction under endoscopy/robot and conventional surgery from January 1, 2025 to December 31, 2028. The perioperative complications, tumor safety and patient reported outcomes of the two methods were compared.

CONDITIONS

Official Title

Endoscopic and Robotic NSM with Immediate Prosthesis Breast Reconstruction

Who Can Participate

FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Underwent surgical treatment at Peking University People's Hospital with hospitalization records
  • Breast cancer confirmed by preoperative core needle biopsy
  • Clinical tumor stage 0 to IIIB
  • Tumor size 5 cm or less, clinical node status cN0 or cN1, no distant metastasis (M0)
  • No tumor invasion of the nipple areola complex, skin, or chest wall
  • Intraoperative plan to use non-biological patches (e.g., TiLoop) to wrap the prosthesis partially or completely
  • Signed agreement to participate in the study
  • Able to complete Patient Reported Outcome Measures (PROMs) questionnaire
Not Eligible

You will not qualify if you...

  • Lack of clinical pathological data such as imaging or pathology reports
  • Pregnancy or lactation
  • Metastatic breast cancer or bilateral breast cancer
  • Previous breast conserving surgery or chest radiation therapy
  • Nipple areola complex invasion requiring removal
  • Failure to undergo curative surgery

AI-Screening

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Trial Site Locations

Total: 1 location

1

Peking University People's Hospital

Beijing, Beijing Municipality, China, 100044

Actively Recruiting

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Research Team

Y

yuan peng, doctor

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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