Comparing cold dissection and electrocautery in nipple-sparing mastectomy with reconstruction
Official title: Necrosis After Cold Dissection Versus Electrocautery Dissection in Endoscopic Nipple-Sparing Mastectomy and Immediate Implant-Based Reconstruction: A Prospective Randomized Controlled Trial
Run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · NCT06024187 · Data updated 2026-11-12
This study is testing whether using cold dissection instead of electrocautery during nipple-sparing mastectomy can lead to fewer complications and better cosmetic results for patients getting breast reconstruction.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | Women only |
| Enrollment | 566 (estimated) |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | November 23, 2022 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | February 13, 2025 |
| Trial ID | NCT06024187 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women with breast tumors smaller than 5 cm who are eligible for nipple-sparing mastectomy.
✕Probably not a fit
Patients with evidence of nipple-areola complex involvement, chest wall or skin invasion, or severe comorbid conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to compare the effectiveness of cold dissection versus electrocautery dissection in patients undergoing nipple-sparing mastectomy followed by immediate implant-based reconstruction. The study focuses on evaluating whether cold dissection can reduce the incidence of ischemia necrosis and other surgical complications, while also improving aesthetic outcomes. Participants will be randomly assigned to receive one of the two surgical techniques, and their postoperative results will be closely monitored. The trial is based on previous findings suggesting that cold dissection may lead to better outcomes compared to electrocautery.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and aesthetic results for patients undergoing mastectomy and reconstruction.
How similar studies have gone: Previous studies have indicated that cold dissection may reduce complications compared to electrocautery, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Shicheng Su
Guangzhou, Guangdong, China Recruiting
Study contacts
- Principal investigator: Shicheng Su — Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Study coordinator: Shicheng Su
- Email: sushch@mail.sysu.edu.cn
- Phone: +86 13631304227
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.