Prospective Cohort Study of Minimally Invasive Surgery Versus Traditional Open Surgery for Nipple Areola Preserving Mastectomy Combined with Immediate Prosthesis Reconstruction
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Nipple-sparing Mastectomy
- Sponsor
- Peking University People's Hospital
- Enrollment
- 484
- Locations
- 1
- Primary Endpoint
- incidence of postoperative complications
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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.
Investigators
Shu Wang
director of breast center
Peking University People's Hospital
Eligibility Criteria
Inclusion Criteria
- •Underwent surgical treatment at Peking University People's Hospital, with hospitalization records;
- •Preoperative core needle biopsy confirmed breast cancer;
- •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;
- •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
- •Lack of clinical pathological data (such as imaging data, pathological data);
- •Pregnancy or lactation period;
- •Patients with metastatic breast cancer or bilateral breast cancer;
- •Have undergone breast conserving surgery/chest radiation therapy before;
- •Patients with nipple areola invasion and subsequent removal of nipple areola complex;
- •Failed to undergo curative surgery;
Outcomes
Primary Outcomes
incidence of postoperative complications
Time Frame: 3 months
Delayed wound healing, nipple and areola ischemia/necrosis, skin ischemia/necrosis, serum swelling, wound dehiscence/prosthesis exposure, infection, and prosthesis removal occurred within 3 months after surgery.
Secondary Outcomes
- Patient-reported Outcome Measures(1 year)
- local-regional recurrence(5 years)
- Distant metastasis free survival(5 years)
- Disease free survival(5 years)