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

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ClinicalTrials.gov Identifier: NCT06024187
Recruitment Status : Recruiting
First Posted : September 6, 2023
Last Update Posted : September 6, 2023
Sponsor:
Information provided by (Responsible Party):
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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
Estimated Primary Completion Date : May 31, 2024
Estimated Study Completion Date : May 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mastectomy

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Tissue necrosis rate [ Time Frame: 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 :
  1. Surgical-site infection rate(SSI) [ Time Frame: within one year post operation ]
    the incidence of surgical-site infection will be compared between two groups

  2. The incidence of postoperative complications [ Time Frame: within one year post operation ]
    the incidence of seroma, hematoma, blister, implant capsular contracture, and implant loss will be compared between two groups

  3. Cosmetic outcomes evaluated by 5-point Likert Scale [ Time Frame: 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.

  4. Patient-reported outcomes (as measured using the BREAST-Q score) [ Time Frame: 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.

  5. Postoperative pain [ Time Frame: 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.

  6. Total operation time [ Time Frame: Immediate post operation ]
    Defined as the time calculated from the skin incision to the end of wound closure

  7. Intraoperative estimated blood loss [ Time Frame: Immediate post operation ]
    Blood loss (ml) during operation was compared between groups

  8. Drain volume [ Time Frame: within three days post operation ]
    Total drain volume(ml) within three days post operation

  9. Duration of hospital stay post operation [ Time Frame: Within 2 weeks of operation. ]
    Duration of hospital stay post operation(d) will be compared between two group.

  10. Weight of the excised gland [ Time Frame: Immediate post operation ]
    Mean mastectomy weight of patients will be compared between two groups.

  11. Size of implant [ Time Frame: Immediate post operation ]
    Size of implant will be compared between two groups.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06024187


Contacts
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Contact: Shicheng Su +86 13631304227 sushch@mail.sysu.edu.cn

Locations
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China, Guangdong
Shicheng Su Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Shicheng Su, M.D.,Ph.D.    +8613631304227    sushch@mail.sysu.edu.cn   
Sponsors and Collaborators
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Investigators
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Principal Investigator: Shicheng Su Sun Yat-sen Memorial Hospital,Sun Yat-sen University
More Information
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Responsible Party: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT06024187    
Other Study ID Numbers: SYSKY-2022-371-02
First Posted: September 6, 2023    Key Record Dates
Last Update Posted: September 6, 2023
Last Verified: September 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University:
Endoscopy
Mastectomy
Breast Implants
Necrosis
Dissection
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases