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

RecruitingNAAges 18 Years - 75 YearsFemaleSun Yat-Sen Memorial Hospital of Sun Yat-Sen Univ…
NCT06024187 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Cold dissection
  • Electrocautery Dissection
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Where

1 site
Shicheng Su
Guangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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