Cold Dissection Versus Electrocautery Dissection in Endoscopic Nipple-Sparing Mastectomy and Immediate Implant-Based Reconstruction: A Randomized Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cold dissection, Electrocautery Dissection.
- Who it may be relevant to
- Registry conditions: Breast Neoplasms. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Necrosis After Cold Dissection Versus Electrocautery Dissection in Endoscopic Nipple-Sparing Mastectomy and Immediate Implant-Based Reconstruction: A Prospective Randomized Controlled Trial
Overview
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.
Interventions
- 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 - 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.
Primary outcome measures
- Necrosis complications within one month post operation [Time frame: Within one month post operation]
Secondary outcome measures (12)
- Necrotic complications within 1 year post operation [Time frame: Within 1 year post operation]
- Surgical-site infection rate(SSI) [Time frame: within one year post operation]
- The incidence of postoperative complications [Time frame: within one year post operation]
- 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.]
- 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.]
- Postoperative pain [Time frame: Evaluated at the first day, second day, third day and the first week, second week.]
- Total operation time [Time frame: Immediate post operation]
- Intraoperative estimated blood loss [Time frame: Immediate post operation]
- Drain volume [Time frame: within three days post operation]
- Duration of hospital stay post operation [Time frame: Within 2 weeks of operation.]
- Weight of the excised gland [Time frame: Immediate post operation]
- Size of implant [Time frame: Immediate post operation]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shicheng Su — Guangzhou
Identifiers
NCT: NCT06024187 · SYSKY-2022-371-02