Cold Dissection Versus Electrocautery Dissection in Endoscopic Nipple-Sparing Mastectomy and Immediate Implant-Based Reconstruction: A Randomized Controlled Trial

Recruiting now · Not applicable

Conditions studied: Breast Neoplasms

In brief

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. 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.

Key facts

Study ID

NCT06024187

Run by

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

People needed

566

Starts

2022-11-23

Expected to finish

2026-12-31

Last updated by the study team

2025-02-13

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Shicheng Su — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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