Trials / Recruiting
RecruitingNCT06748677
Endoscopic and Robotic NSM with Immediate Prosthesis Breast Reconstruction
Prospective Cohort Study of Minimally Invasive Surgery Versus Traditional Open Surgery for Nipple Areola Preserving Mastectomy Combined with Immediate Prosthesis Reconstruction
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 484 (estimated)
- Sponsor
- Peking University People's Hospital · Academic / Other
- Sex
- Female
- Age
- —
- Healthy volunteers
- Not accepted
Summary
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
Timeline
- Start date
- 2025-01-03
- Primary completion
- 2028-12-31
- Completion
- 2031-12-31
- First posted
- 2024-12-27
- Last updated
- 2025-01-07
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06748677. Inclusion in this directory is not an endorsement.