Prospective Clinical Study of Single Port Endoscopic Breast Conserving Surgery or Open Breast Conserving Surgery for Early Breast Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Six months after operation SURVIVAL EFFECTS
Study Overview
Brief Summary
The center plans to carry out a prospective clinical study of single hole total endoscopic breast conserving surgery for early breast cancer compared with open breast conserving surgery, to provide high-level evidence-based medical evidence for the development of endoscopic breast conserving surgery for early breast cancer.
Detailed Description
Data show that breast cancer has surpassed lung cancer asthemost prevalent malignant tumor in the world, and traditional open surgery is highly invasive and has poor cosmetic results. This study investigates the results of endoscopic breast- conserving surgery(E-BCS) versus conventional breast-conserving surgery(C-BCS) in the treatment of patients with early-stage breast cancer and to compare the advantages and disadvantages of the two surgical procedures, so as to provide the best evidence for the rational choice of the procedure by both doctors and patients.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 20 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Breast cancer confirmed by pathology；
- •Tumor <5 cm, TNM stage 0-II；
- •Single Port Endoscopic or traditional open surgery; (4)20 to 70 years old female patients.
Exclusion Criteria
- •Bilateral breast cancer;
- •Reconstruction after breast conserving surgery ;
- •Basic information is not complete；
- •Breast conserving surgery was converted to modified radical resection or subcutaneous adenoidectomy.
Outcomes
Primary Outcomes
Six months after operation SURVIVAL EFFECTS
Time Frame: From enrollment to the end of 6 months after surgery
To compare the overall survival (OS) within 6 months after single-port endoscopic breast-conserving surgery and open breast-conserving surgery.
Secondary Outcomes
- Intraoperative blood loss(From the beginning to the end of the operation)
- Postoperative drainage volume in the first three days after breast conserving surgery(3 days after surgery)
- Length of surgical incision(1 week after surgery)
Investigators
Ren,Yu
chief physician
First Affiliated Hospital Xi'an Jiaotong University