Cold Dissection Versus Electrocautery Dissection in Endoscopic Nipple-Sparing Mastectomy and Immediate Implant-Based Reconstruction: A Randomized Controlled Trial
- Conditions
- Breast Neoplasms
- Interventions
- Procedure: Electrocautery DissectionProcedure: Cold dissection
- Registration Number
- NCT06024187
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 566
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Electrocautery Dissection Electrocautery Dissection In this group, the septa between the skin flap and parenchyma was dissected using with electrocautery Cold Dissection Cold dissection In this group, the septa between the skin flap and parenchyma was dissected using with scissors or scalpel
- Primary Outcome Measures
Name Time Method Necrosis complications within one month post operation Within one month post operation Necrosis complications 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
Name Time Method Necrotic complications within 1 year post operation Within 1 year post operation Surgical-site infection rate(SSI) within one year post operation the incidence of surgical-site infection will be compared between two groups
Patient-reported outcomes (as measured using the BREAST-Q score) 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.
The incidence of postoperative complications within one year post operation 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 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.
Postoperative pain 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.
Total operation time Immediate post operation Defined as the time calculated from the skin incision to the end of wound closure
Drain volume within three days post operation Total drain volume(ml) within three days post operation
Intraoperative estimated blood loss Immediate post operation Blood loss (ml) during operation was compared between groups
Duration of hospital stay post operation Within 2 weeks of operation. Duration of hospital stay post operation(d) will be compared between two group.
Weight of the excised gland Immediate post operation Mean mastectomy weight of patients will be compared between two groups.
Size of implant Immediate post operation Size of implant will be compared between two groups.
Trial Locations
- Locations (1)
Shicheng Su
🇨🇳Guangzhou, Guangdong, China