Clinical trial NCT06024187: 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
Overall status: RECRUITING
Phase: NA
Conditions: Breast Neoplasms
Keywords: Endoscopy
Mastectomy
Breast Implants
Necrosis
Dissection
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-09-06
Enrollment: 566
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Necrosis complications within one month post operation
timeFrame: Within one month post operation
Secondary outcomes:
measure: Necrotic complications within 1 year post operation
timeFrame: Within 1 year post operation
measure: Surgical-site infection rate(SSI)
timeFrame: within one year post operation
measure: The incidence of postoperative complications
timeFrame: within one year post operation
measure: Cosmetic outcomes evaluated by 5-point Likert Scale
timeFrame: Evaluated pre-operation, at the first month, at 2 months, 3 months, 6 months and 12 months.
measure: Patient-reported outcomes (as measured using the BREAST-Q score)
timeFrame: Evaluated pre-operation, at the first month, at 2 months, 3 months, 6 months and 12 months.
measure: Postoperative pain
timeFrame: Evaluated at the first day, second day, third day and the first week, second week.
measure: Total operation time
timeFrame: Immediate post operation
measure: Intraoperative estimated blood loss
timeFrame: Immediate post operation
measure: Drain volume
timeFrame: within three days post operation
measure: Duration of hospital stay post operation
timeFrame: Within 2 weeks of operation.
measure: Weight of the excised gland
timeFrame: Immediate post operation
measure: Size of implant
timeFrame: Immediate post operation
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Shicheng Su
state: Guangdong
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Shicheng Su
role: PRINCIPAL_INVESTIGATOR
References: