Single Port Endoscopic Breast Conserving Surgery

Recruiting

• Conditions: Breast Conserving Surgery; Endoscopic Surgery
• Interventions: Procedure: endoscopic breast conserving surgery

• Registration Number: NCT06593132
• Lead Sponsor: Ren,Yu

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 Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2024-08-27
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-10
• Last Update Submitted: 2024-09-10
• Study First Posted: 2024-09-12
• Last Update Posted: 2024-09-12
• Primary Completion: 2024-12
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

1. Breast cancer confirmed by pathology；
2. Tumor <5 cm, TNM stage 0-II；
3. Single Port Endoscopic or traditional open surgery; (4)20 to 70 years old female patients.

Exclusion Criteria

1. Bilateral breast cancer;
2. Reconstruction after breast conserving surgery ;
3. Basic information is not complete；
4. Breast conserving surgery was converted to modified radical resection or subcutaneous adenoidectomy.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
single port endoscopic breast conserving surgery	endoscopic breast conserving surgery	Endoscopic breast conserving surgery, which uses breast endoscope for breast conserving surgery, can not only preserve the breast completely, but also meet the appearance needs of patients with breast preservation, and has more advantages than traditional surgery.
open breast conserving surgery	endoscopic breast conserving surgery	On the surface of the breast tumor centered, is apart from the 2 cm do arc, radial incision tumor, tags in the cut edge around the joints and removing tissue inspection, to ensure the cut edge negative.

Primary Outcome Measures

Name	Time	Method
Six months after operation SURVIVAL EFFECTS	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 Outcome Measures

Name	Time	Method
Intraoperative blood loss	From the beginning to the end of the operation	To compare the total blood loss between single-port endoscopic breast-conserving surgery and open breast-conserving surgery.
Postoperative drainage volume in the first three days after breast conserving surgery	3 days after surgery	The total drainage volume in the first three days after breast conserving surgery was compared between single-port endoscopic breast conserving surgery and open breast conserving surgery.
Length of surgical incision	1 week after surgery	The total incision length was compared between single-port endoscopic breast-conserving surgery and open breast-conserving surgery.

Trial Locations

Locations (1)

the First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China