Single Port Endoscopic Breast Conserving Surgery

NCT06593132 | Recruiting

• 1 other identifier: SPEBCS-2023
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Conserving Surgery; Endoscopic Surgery

Keywords

breast conserving surgery; single port endoscopic; early breast cancer

Outcome Measures

Primary Outcomes (1)

• Six months after operation SURVIVAL EFFECTS

  To compare the overall survival (OS) within 6 months after single-port endoscopic breast-conserving surgery and open breast-conserving surgery.

  From enrollment to the end of 6 months after surgery

Secondary Outcomes (3)

• 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

Study Arms (2)

single port 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.

Procedure: endoscopic breast conserving surgery

open 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.

Procedure: endoscopic breast conserving surgery

Interventions

endoscopic breast conserving surgery PROCEDURE

Breast endoscopy technology completes complex surgical operations through small incisions, achieving aesthetically pleasing results while ensuring tumor safety.

open breast conserving surgery; single port endoscopic breast conserving surgery

Eligibility Criteria

• Age: 20 Years - 70 Years
• Gender Eligibility Details: All participants are women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Female patients aged 20-70 years who are eligible for breast-conserving surgery and are willing to undergo breast-conserving surgery.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ren,Yu: lead

Study Sites (1)

the First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Zhaoli Nan, bacheior

CONTACT

15114822852; 369075227@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: September 19, 2024
• Study Start: January 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: June 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)