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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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
• Процедура 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.

Первичные конечные точки

• Necrosis complications within one month post operation [Срок оценки: Within one month post operation]

Вторичные конечные точки (12)

• Necrotic complications within 1 year post operation [Срок оценки: Within 1 year post operation]
• Surgical-site infection rate(SSI) [Срок оценки: within one year post operation]
• The incidence of postoperative complications [Срок оценки: within one year post operation]
• Cosmetic outcomes evaluated by 5-point Likert Scale [Срок оценки: 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) [Срок оценки: Evaluated pre-operation, at the first month, at 2 months, 3 months, 6 months and 12 months.]
• Postoperative pain [Срок оценки: Evaluated at the first day, second day, third day and the first week, second week.]
• Total operation time [Срок оценки: Immediate post operation]
• Intraoperative estimated blood loss [Срок оценки: Immediate post operation]
• Drain volume [Срок оценки: within three days post operation]
• Duration of hospital stay post operation [Срок оценки: Within 2 weeks of operation.]
• Weight of the excised gland [Срок оценки: Immediate post operation]
• Size of implant [Срок оценки: Immediate post operation]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shicheng Su — Гуанчжоу

Идентификаторы

NCT: NCT06024187 · SYSKY-2022-371-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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