RecruitingNot ApplicableNCT06024187

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

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

Sponsor

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

Enrollment

566 participants

Start Date

Nov 23, 2022

Study Type

INTERVENTIONAL

Conditions

Breast Neoplasms

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

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Inclusion Criteria2

Tumor smaller than 5 cm
No evidence of NAC, skin or chest wall invasion.

Exclusion Criteria1

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.

Interventions

PROCEDURECold dissection

The subcutaneous flap dissection was performed with a scissor in this group. The boundary of mastectomy flap was defined as the edge of clavicle superiorly, the edge of sternum medially, the edge of inframammary fold inferiorly, and the edge of the latissimus dorsi laterally. Our tumescent technique utilizes a solution made by mixing 0.2ml of epinephrine with 250 ml of 0.9% Sodium Chloride solution to create a 1‰ ratio. 150ml to 150ml of the solution was injected into the subcutaneous tissue of the operated breast with a 20-gauge spinal needle to establish a bloodless plane. The septa between the skin flap and parenchyma then was dissected using a scissor.

PROCEDUREElectrocautery Dissection

The subcutaneous flap dissection was performed with electrocautery in this group. The boundary of mastectomy flap was defined as the edge of clavicle superiorly, the edge of sternum medially, the edge of inframammary fold inferiorly, and the edge of the latissimus dorsi laterally.