Status:
RECRUITING
Cold Dissection Versus Electrocautery Dissection in Endoscopic Nipple-Sparing Mastectomy and Immediate Implant-Based Reconstruction: A Randomized Controlled Trial
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
18-75 years
Phase:
NA
Brief Summary
The purpose of this study is to analyze whether cold dissection can decrease the rate of ischemia necrosis and other complications and then increase the aesthetic outcomes compared to electrocautery. ...
Detailed Description
Breast cancer is the most common cancer among women in the world. Although breast-conserving surgery is a viable option for patients, mastectomy remains the choice of treatment. Despite oncologic and ...
Eligibility Criteria
Inclusion
- Tumor smaller than 5 cm
- No evidence of NAC, skin or chest wall invasion.
- The general inclusion criteria or pre-requisite for nipple sparing mastectomy apply to E-NSM as well.
Exclusion
- Patients with apparent NAC involvement, chest wall or skin invasion, inflammatory breast cancer, locally advanced breast cancer or severe comorbid conditions or poor performance status assessed by the primary physicians, such as heart disease, renal failure, liver dysfunction, and poor performance status as assessed by the primary physicians.
Key Trial Info
Start Date :
November 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
566 Patients enrolled
Trial Details
Trial ID
NCT06024187
Start Date
November 23 2022
End Date
December 31 2026
Last Update
February 13 2025
Active Locations (1)
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1
Shicheng Su
Guangzhou, Guangdong, China, 510120