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

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06024187
• Other study ID #: SYSKY-2022-371-02
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: May 31, 2024

Study information

• Verified date: September 2023
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Shicheng Su
• Phone: +86 13631304227
• Email: sushch[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Breast cancer is the most common cancer among women in the world. Although breast-conserving surgery is a viable option for patients, mastectomy remains the choice of treatment. Despite oncologic and surgical safety of nipple-sparing mastectomy(NSM) with immediate breast reconstruction(IBR) were amply demonstrated, a number of acute and late complications can occur. Surgical technique may play a role in the postoperative outcomes of mastectomy skin flap.Previous studies suggest that cold dissection with scissors or scalpel, may lead to decreasing blood loss and rates of skin necrosis, compared to electrocautery. A retrospective study by Troy Ng demonstrated that the use of cold dissection is likely to decrease the rate of partial-thickness necrosis (13.0%→33.3%, p=0.01) and full-thickness necrosis (1.3%→12.8%, p=0.02). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 234
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Procedure:
• Cold 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.
• Electrocautery 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.

Locations

Country	Name	City	State
China	Shicheng Su	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tissue necrosis rate	Tissue necrosis included nipple-areolar complex (NAC) and skin flap necrosis. NAC/skin flap necrosis could present as minor superficial epidermolysis requiring local wound care only, or full-thickness necrosis with any exposure of acellular dermal matrix, muscle, implant, or with full-thickness eschar that required surgical reoperation of debridement and repair.	within one year post operation
Secondary	Surgical-site infection rate(SSI)	the incidence of surgical-site infection will be compared between two groups	within one year post operation
Secondary	The incidence of postoperative complications	the incidence of seroma, hematoma, blister, implant capsular contracture, and implant loss will be compared between two groups	within one year post operation
Secondary	Cosmetic outcomes evaluated by 5-point Likert Scale	Evaluated by patients and five surgeons. In this scale, breast fullness; nipple-areola complex, shape, and contour; scar appearance, size, and fullness; and overall breast appearance will be assessed.	Evaluated pre-operation, at the first month, at 2 months, 3 months, 6 months and 12 months.
Secondary	Patient-reported outcomes (as measured using the BREAST-Q score)	The modules included Satisfaction with Breasts, Psychosocial Wellbeing, Sexual Wellbeing, and Physical Wellbeing Chest, Surgeon, Medical Staff, Office Staff.	Evaluated pre-operation, at the first month, at 2 months, 3 months, 6 months and 12 months.
Secondary	Postoperative pain	Pain was assessed using a visual analogue scale(VAS), where 0 = no pain and 10 = worst possible pain.	Evaluated at the first day, second day, third day and the first week, second week.
Secondary	Total operation time	Defined as the time calculated from the skin incision to the end of wound closure	Immediate post operation
Secondary	Intraoperative estimated blood loss	Blood loss (ml) during operation was compared between groups	Immediate post operation
Secondary	Drain volume	Total drain volume(ml) within three days post operation	within three days post operation
Secondary	Duration of hospital stay post operation	Duration of hospital stay post operation(d) will be compared between two group.	Within 2 weeks of operation.
Secondary	Weight of the excised gland	Mean mastectomy weight of patients will be compared between two groups.	Immediate post operation
Secondary	Size of implant	Size of implant will be compared between two groups.	Immediate post operation