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Идёт набор NCT05449691

Biological Matrices Versus Synthetic Meshes

Без фазы С лечением 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: One-stage immediate breast reconstruction.
Кому может быть актуально
Состояния в реестре: Breast Cancer. 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
Великобритания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

BIOSYM - A Feasibility Randomised Controlled Trial Comparing Biological Matrices With Synthetic Meshes in Women Undergoing One Stage Implant Based Breast Reconstruction

Обзор

In this feasibility study, 60 women undergoing reconstruction will be randomly allocated to receive biological or synthetic mesh and followed for 6 months. The findings will tell us if patients and surgeons are comfortable with not being able to choose which mesh is used for the operation. In the larger surgical study, the investigators plan to measure patients' satisfaction with the reconstruction, patients' quality of life, complications from the operation and costs over 5 years.

Подробное описание

Immediate breast reconstruction in women undergoing removal of the whole breast for cancer or risk reduction is most commonly done using breast implants. Surgeons often use a sheet of mesh to cover the implant as standard treatment. It acts like an internal bra and supports the implant and re-creates a natural looking breast.

Natural(biological) or man-made (synthetic) meshes are used routinely in the NHS. Biological ones are made from animal tissue (pig, cow) that have been made safe to use in people and are costly. Synthetic meshes are made from net-like fabric and cost less. The choice about which mesh to use depends on surgeons' personal experience and how much money the hospital has for these operations. The two meshes may have different acceptability issues for patients because of their personal values, religious beliefs, ethnic background or views on animal welfare.

A large UK review of breast reconstruction with implants gathered information up to 3 months after surgery on the use and outcomes of the two meshes. This suggests that both may be equally safe in the short-term. However, this information can be improved by comparing the meshes side-by-side and looking at how safe they are long-term. This is important as some side-effects only appear later after surgery. Clinicians do not know how outcomes impact on patients' health and well-being.

The best proof would come from a randomised surgical study, where a computer allocates patients to receive either the biological or synthetic mesh. Investigators will measure how patients feel, how their health is, and record if they have any side-effects from the reconstructive surgery. This type of study would tell us how good each mesh is and if they are safe long-term.

Before starting such a study, investigators will run a smaller one that will help us understand if patients and surgeons would be comfortable taking part.

Вмешательства

  • Процедура One-stage immediate breast reconstruction
    One-stage mesh assisted implant breast reconstruction

Первичные конечные точки

  • Clinician acceptance [Срок оценки: 2 years]
  • Patient acceptance [Срок оценки: 2 years]
  • Recruitment rate [Срок оценки: 2 years]
  • Compliance with allocated intervention [Срок оценки: 2 years]

Критерии участия

Критерии включения

Female age ≥ 18 Women undergoing mastectomy and immediate one-stage mesh assisted implant breast reconstruction as standard treatment

Критерии исключения

Revision reconstruction surgery Delayed reconstruction surgery

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

Великобритания · 5 центров
  • University Hospitals of Derby and Burton NHS Foundation Trust — Derby
  • Wycombe Hospital — High Wycombe
  • Castle Hill Hospital — Hull
  • University Hospitals of Leicester NHS Trust — Leicester
  • Nottingham City Hospital — Nottingham

Идентификаторы

NCT: NCT05449691 · 315581

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗