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

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06024187

Collaborator

(none)

234

Enrollment

Location

Arms

Anticipated Duration (Months)

9.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasms	Procedure: Cold dissection Procedure: Electrocautery Dissection	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

234 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Patients who met the inclusion criteria and received informed consent were randomly assigned to the group of using cold separation or the group of using electrocautery with 1:1 allocation based on a computer-generated randomization schedule. The randomization was conducted by drawing an envelope containing the allocation to one of the two intervention groups.Patients who met the inclusion criteria and received informed consent were randomly assigned to the group of using cold separation or the group of using electrocautery with 1:1 allocation based on a computer-generated randomization schedule. The randomization was conducted by drawing an envelope containing the allocation to one of the two intervention groups.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

May 31, 2024

Anticipated Study Completion Date :

May 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cold Dissection In this group, the septa between the skin flap and parenchyma was dissected using with scissors or scalpel	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.
Active Comparator: Electrocautery Dissection In this group, the septa between the skin flap and parenchyma was dissected using with electrocautery	Procedure: 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.

Arm

Intervention/Treatment

Experimental: Cold Dissection

In this group, the septa between the skin flap and parenchyma was dissected using with scissors or scalpel

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.

Active Comparator: Electrocautery Dissection

In this group, the septa between the skin flap and parenchyma was dissected using with electrocautery

Procedure: 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.

Outcome Measures

Primary Outcome Measures

Tissue necrosis rate [within one year post operation]
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.

Secondary Outcome Measures

Surgical-site infection rate(SSI) [within one year post operation]
the incidence of surgical-site infection will be compared between two groups
The incidence of postoperative complications [within one year post operation]
the incidence of seroma, hematoma, blister, implant capsular contracture, and implant loss will be compared between two groups
Cosmetic outcomes evaluated by 5-point Likert Scale [Evaluated pre-operation, at the first month, at 2 months, 3 months, 6 months and 12 months.]
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.
Patient-reported outcomes (as measured using the BREAST-Q score) [Evaluated pre-operation, at the first month, at 2 months, 3 months, 6 months and 12 months.]
The modules included Satisfaction with Breasts, Psychosocial Wellbeing, Sexual Wellbeing, and Physical Wellbeing Chest, Surgeon, Medical Staff, Office Staff.
Postoperative pain [Evaluated at the first day, second day, third day and the first week, second week.]
Pain was assessed using a visual analogue scale(VAS), where 0 = no pain and 10 = worst possible pain.
Total operation time [Immediate post operation]
Defined as the time calculated from the skin incision to the end of wound closure
Intraoperative estimated blood loss [Immediate post operation]
Blood loss (ml) during operation was compared between groups
Drain volume [within three days post operation]
Total drain volume(ml) within three days post operation
Duration of hospital stay post operation [Within 2 weeks of operation.]
Duration of hospital stay post operation(d) will be compared between two group.
Weight of the excised gland [Immediate post operation]
Mean mastectomy weight of patients will be compared between two groups.
Size of implant [Immediate post operation]
Size of implant will be compared between two groups.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.