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

Primary Purpose

Breast Neoplasms

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Cold dissection
Electrocautery Dissection
Sponsored by
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Neoplasms focused on measuring Endoscopy, Mastectomy, Breast Implants, Necrosis, Dissection

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • Shicheng SuRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cold Dissection

Electrocautery Dissection

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Surgical-site infection rate(SSI)
the incidence of surgical-site infection will be compared between two groups
The incidence of postoperative complications
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 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)
The modules included Satisfaction with Breasts, Psychosocial Wellbeing, Sexual Wellbeing, and Physical Wellbeing Chest, Surgeon, Medical Staff, Office Staff.
Postoperative pain
Pain was assessed using a visual analogue scale(VAS), where 0 = no pain and 10 = worst possible pain.
Total operation time
Defined as the time calculated from the skin incision to the end of wound closure
Intraoperative estimated blood loss
Blood loss (ml) during operation was compared between groups
Drain volume
Total drain volume(ml) within three days post operation
Duration of hospital stay post operation
Duration of hospital stay post operation(d) will be compared between two group.
Weight of the excised gland
Mean mastectomy weight of patients will be compared between two groups.
Size of implant
Size of implant will be compared between two groups.

Full Information

First Posted
November 30, 2022
Last Updated
September 4, 2023
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT06024187
Brief Title
Cold Dissection Versus Electrocautery Dissection in Endoscopic Nipple-Sparing Mastectomy and Immediate Implant-Based Reconstruction: A Randomized Controlled 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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms
Keywords
Endoscopy, Mastectomy, Breast Implants, Necrosis, Dissection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
234 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cold Dissection
Arm Type
Experimental
Arm Description
In this group, the septa between the skin flap and parenchyma was dissected using with scissors or scalpel
Arm Title
Electrocautery Dissection
Arm Type
Active Comparator
Arm Description
In this group, the septa between the skin flap and parenchyma was dissected using with electrocautery
Intervention Type
Procedure
Intervention Name(s)
Cold dissection
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Electrocautery Dissection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Tissue necrosis rate
Description
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.
Time Frame
within one year post operation
Secondary Outcome Measure Information:
Title
Surgical-site infection rate(SSI)
Description
the incidence of surgical-site infection will be compared between two groups
Time Frame
within one year post operation
Title
The incidence of postoperative complications
Description
the incidence of seroma, hematoma, blister, implant capsular contracture, and implant loss will be compared between two groups
Time Frame
within one year post operation
Title
Cosmetic outcomes evaluated by 5-point Likert Scale
Description
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.
Time Frame
Evaluated pre-operation, at the first month, at 2 months, 3 months, 6 months and 12 months.
Title
Patient-reported outcomes (as measured using the BREAST-Q score)
Description
The modules included Satisfaction with Breasts, Psychosocial Wellbeing, Sexual Wellbeing, and Physical Wellbeing Chest, Surgeon, Medical Staff, Office Staff.
Time Frame
Evaluated pre-operation, at the first month, at 2 months, 3 months, 6 months and 12 months.
Title
Postoperative pain
Description
Pain was assessed using a visual analogue scale(VAS), where 0 = no pain and 10 = worst possible pain.
Time Frame
Evaluated at the first day, second day, third day and the first week, second week.
Title
Total operation time
Description
Defined as the time calculated from the skin incision to the end of wound closure
Time Frame
Immediate post operation
Title
Intraoperative estimated blood loss
Description
Blood loss (ml) during operation was compared between groups
Time Frame
Immediate post operation
Title
Drain volume
Description
Total drain volume(ml) within three days post operation
Time Frame
within three days post operation
Title
Duration of hospital stay post operation
Description
Duration of hospital stay post operation(d) will be compared between two group.
Time Frame
Within 2 weeks of operation.
Title
Weight of the excised gland
Description
Mean mastectomy weight of patients will be compared between two groups.
Time Frame
Immediate post operation
Title
Size of implant
Description
Size of implant will be compared between two groups.
Time Frame
Immediate post operation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shicheng Su
Phone
+86 13631304227
Email
sushch@mail.sysu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shicheng Su
Organizational Affiliation
Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shicheng Su
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shicheng Su, M.D.,Ph.D.
Phone
+8613631304227
Email
sushch@mail.sysu.edu.cn

12. IPD Sharing Statement

Learn more about this trial

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

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