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

RECRUITINGN/ASponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Actively Recruiting
PhaseN/A
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Started2022-11-23
Est. completion2026-12-31
Eligibility
Age18 Years – 75 Years
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06024187

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. 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.

Eligibility

Age: 18 Years – 75 YearsSex: FEMALEHealthy volunteers accepted
Inclusion Criteria:

* 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 Criteria:

* 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.

Conditions3

Breast CancerBreast NeoplasmsCancer

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