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Идёт набор NCT05833659

Comparison Between Prepectoral and Subpectoral Breast Reconstruction

— Наблюдательное Stage II Breast Cancer Stage I Breast Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: The breast reconstruction method after single-port insufflation endoscopic nipple-sparing mastectomy.
Кому может быть актуально
Состояния в реестре: Stage II Breast Cancer, Stage I Breast Cancer. Базовые параметры: 18 лет — 70 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

The Comparison Between Prepectoral Breast Reconstruction and Subpectoral Breast Reconstruction Following Single-port Insufflation Endoscopic Nipple-sparing Mastectomy

Обзор

There are controversies about breast implant-based reconstruction techniques. Our center pioneered single-port insufflation endoscopic nipple-sparing mastectomy (SIE-NSM) combined with stage I prosthesis reconstruction. The study's primary objective is to compare single-port endoscopic NSM combined with pre-pectoral breast reconstruction to the subpectoral breast reconstruction group regarding breast satisfaction. This study is an ambispective cohort study. The study will be conducted at Beijing Friendship Hospital, affiliated with Capital Medical University. Patients will be enrolled retrospectively from January 2014 to March 2022 by reviewing the medical records and recruited prospectively from March 2022 to March 2025. The two cohorts are the pre-pectoral breast reconstruction cohort and the subpectoral breast reconstruction cohort, both following single-port insufflation endoscopic nipple-sparing mastectomy. The primary outcome of this study is postoperative breast satisfaction, which the BREAST-Q score will measure. The different variables will be compared using the Χ2 test for categorical variables and the Mann-Whitney test for continuous variables.

Подробное описание

Sample size and statistical analysis This study is an ambispective cohort study. According to the previous retrospective research data of the center, the breast satisfaction score is the main research object. The standard deviation was 2.6, the non-inferiority margin was 0.15, the test level was α=0.05, β=0.2, and a one-sided test was performed. Eighty patients will be needed for two cohorts in a 1:1 ratio. Considering the 10% loss to follow-up rate, 44 patients will be required to be enrolled in each group.

Вмешательства

  • Процедура The breast reconstruction method after single-port insufflation endoscopic nipple-sparing mastectomy
    Group A:The prepectoral breast reconstruction. Group B:The subpectoral breast reconstruction

Первичные конечные точки

  • breast satisfaction [Срок оценки: 12 months after operation]
Вторичные конечные точки (4)
  • Physical well-being of chest [Срок оценки: 12 months after operation]
  • Animation deformity [Срок оценки: 12 months after operation]
  • Adverse events [Срок оценки: within 30 days after surgery]
  • Local recurrence and distant metastasis of breast cancer [Срок оценки: 12 months after operation]

Критерии участия

Критерии включения

  • Female patients with preoperative pathologically confirmed early-stage invasive breast cancer (stage I or stage II) by core needle biopsy.
  • Breast-conserving surgery is not possible due to the presence of contraindications to breast-conserving surgery, or the patient actively requests total mastectomy.
  • Patients having willingness for breast reconstruction.
  • Age between 18 to 70 years.
  • Maximum diameter of the cancer lesion ≤ 3 cm.
  • Physical examination and breast magnetic resonance imaging (MRI) confirmed that the tumor did not invade the skin, subcutaneous tissue, or chest wall.
  • The distance between the lesion and the nipple is ≥2 cm, and it is confirmed by physical examination and MRI that the nipple-areola complex is not invaded.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status Scale of 0 to 2.

Критерии исключения

  • patients having serious medical diseases, including unstable angina pectoris, myocardial infarction, and cerebrovascular accident within 6 months.
  • Having history of malignant tumor (s) within 5 years.
  • Patients under immunosuppressive therapy for organ transplantation.
  • Having continuous systemic steroid hormone therapy.
  • Pregnant or lactating women.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Beijing Friendship Hospital, Capital medical University — Пекин

Идентификаторы

NCT: NCT05833659 · RESPECT

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗