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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Procedure: Cold dissection
* Procedure: Electrocautery Dissection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cold Dissection<br>In this group, the septa between the skin flap and parenchyma was dissected using with scissors or scalpel | Procedure: Cold dissection<br>* 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.<br>|
| Active Comparator: Electrocautery Dissection<br>In this group, the septa between the skin flap and parenchyma was dissected using with electrocautery | Procedure: Electrocautery Dissection<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical-site infection rate(SSI) | the incidence of surgical-site infection will be compared between two groups | within one year post operation | 
| 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 | 
| 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. | 
| 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. | 
| 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. | 
| Total operation time | Defined as the time calculated from the skin incision to the end of wound closure | Immediate post operation | 
| Intraoperative estimated blood loss | Blood loss (ml) during operation was compared between groups | Immediate post operation | 
| Drain volume | Total drain volume(ml) within three days post operation | within three days post operation | 
| Duration of hospital stay post operation | Duration of hospital stay post operation(d) will be compared between two group. | Within 2 weeks of operation. | 
| Weight of the excised gland | Mean mastectomy weight of patients will be compared between two groups. | Immediate post operation | 
| Size of implant | Size of implant will be compared between two groups. | Immediate post operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopy, Mastectomy, Breast Implants, Necrosis, Dissection