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Набор скоро начнётся NCT07236359

Evaluation of Well Being and Patient Reported Outcomes After Robotic Single-port Nipple Sparing Mastectomy and Implant Reconstruction

Без фазы С лечением Breast Reconstruction Breast Cancer Hereditary Breast/Ovarian Cancer (brca1, brca2) Robotic Surgery

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: Intervention, Standard open nipple sparing mastectomy with immediate implant-based reconstruction.
Кому может быть актуально
Состояния в реестре: Breast Reconstruction, Breast Cancer, Hereditary Breast/Ovarian Cancer (brca1, brca2), Robotic Surgery. Базовые параметры: от 18 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
Список центров уточняется — проверьте первичный протокол.
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

A Randomised Control Trial Evaluating Well Being and Patient Reported Outcomes After Robotic Single-port Nipple Sparing Mastectomy and Implant Reconstruction

Обзор

This study is being carried out to better understand how different types of mastectomy surgeries affect women's recovery, satisfaction, and overall well-being after breast cancer surgery and reconstruction. There are different ways to perform a mastectomy. In some patients, a nipple-sparing mastectomy may be suitable, where the nipple and surrounding breast skin are preserved. This approach allows for immediate breast reconstruction with an implant, which is placed at the same time as the mastectomy to restore the breast shape. A newer technique called robotic single-port nipple-sparing mastectomy uses advanced robotic technology to remove breast tissue through a small hidden incision at the side of the chest. This method may reduce scarring, pain, and recovery time, while preserving the appearance and sensation of the breast. However, while early studies suggest this technique is safe and effective, more evidence is needed to compare it directly with standard surgeries. This study will compare: * Robotic nipple-sparing mastectomy * Standard (open) nipple-sparing mastectomy We will assess patient satisfaction, body image, physical and emotional well-being, and surgical outcomes over 12 months following surgery. By taking part, you are helping researchers evaluate whether robotic and nipple-sparing approaches offer measurable benefits to patients. Taking part in this study will not affect your surgery or the care you receive. You will be given the best treatment available based on your individual medical needs, whether or not you decide to participate in the research.

Вмешательства

  • Процедура Intervention
    Single-port robotic nipple-sparing mastectomy with immediately implant based reconstruction.
  • Процедура Standard open nipple sparing mastectomy with immediate implant-based reconstruction
    Standard open nipple sparing mastectomy with immediate implant-based reconstruction

Первичные конечные точки

  • Secondary Outcome Measures [Срок оценки: 1 year]
  • Primary Outcome Measure [Срок оценки: 1 year]

Критерии участия

Критерии включения

  • Women aged 18 years and older
  • Candidates who have already been selected to undergo nipple sparing mastectomy and immediate implant reconstruction by the breast MDT for the following indications:
  • Genetic mutation carriers undergoing risk-reducing mastectomy.
  • Ductal carcinoma in situ (DCIS) requiring mastectomy.
  • Early invasive breast cancer requiring mastectomy.
  • The tumour must not have skin involvement and no evidence of invasive disease within 1cm of skin, nipple or Pec major muscle (as proven on MRI).
  • Candidates for immediate breast reconstruction with IMPLANT reconstruction
  • Fluent in English
  • Fit for general anaesthetic
  • Signed informed consent form

Критерии исключения

  • Advanced breast cancer with skin involvement.
  • Nipple involvement for Nipple Sparing Mastectomy Arms.
  • Prior chest wall radiation therapy
  • Pregnancy
  • Lactation
  • Patients with insufficient English to sign an informed consent (i.e. interpreter required).

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
Простое слепое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • Toesca A, Sangalli C, Maisonneuve P, Massari G, Girardi A, Baker JL, Lissidini G, Invento A, Farante G, Corso G, Rietjens M, Peradze N, Gottardi A, Magnoni F, Bottiglieri L, Lazzeroni M, Montagna E, Labo P, Orecchia R, Galimberti V, Intra M, Sacchini V, Veronesi P. A Randomized Trial of Robotic Mastectomy Versus Open Surgery in Women With Breast Cancer or BrCA Mutation. Ann Surg. 2022 Jul 1;276(1) PMID 34597010
  • Sarfati B, Honart JF, Leymarie N, Rimareix F, Al Khashnam H, Kolb F. Robotic da Vinci Xi-assisted nipple-sparing mastectomy: First clinical report. Breast J. 2018 May;24(3):373-376. doi: 10.1111/tbj.12937. Epub 2017 Dec 18. PMID 29251382

Идентификаторы

NCT: NCT07236359 · 25/72

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗