Comparing cold dissection and electrocautery in nipple-sparing mastectomy with reconstruction
Necrosis After Cold Dissection Versus Electrocautery Dissection in Endoscopic Nipple-Sparing Mastectomy and Immediate Implant-Based Reconstruction: A Prospective Randomized Controlled Trial
NA · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · NCT06024187
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 566 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (other) |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06024187 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women with breast tumors smaller than 5 cm who are eligible for nipple-sparing mastectomy.
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.
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 performed: Previous studies have indicated that cold dissection may reduce complications compared to electrocautery, suggesting potential success for this approach.
Eligibility criteria
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 this trial is running
Guangzhou, Guangdong
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Neoplasms, Endoscopy, Mastectomy, Breast Implants, Necrosis, Dissection