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临床试验/NCT06133452
NCT06133452已完成不适用

Clinical Outcomes of Patients Undergoing Skin-Reducing Mastectomies: A Long-Term Retrospective Study.

European Institute of Oncology1 个研究点 分布在 1 个国家目标入组 398 人开始时间: 2018年1月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
398
试验地点
1
主要终点
rate of long term complications

研究概览

简要总结

The "mastectomy skin reducing" is a surgical procedure involving the removal of the mammary gland and, simultaneously, reducing the excess skin to enhance the aesthetic appearance in breast reconstruction. This technique is commonly used in patients with an excessive amount of residual skin after breast tissue removal, such as following a mastectomy for breast cancer treatment or prophylactic purposes (in patients at high risk of breast carcinoma due to family history and/or mutations in the Breast Cancers genes ).

The goal of mastectomy skin reducing is to create a breast reconstruction that appears natural and aesthetically harmonious by minimizing excess skin. Excess skin can be removed in two main ways: as a conventional ellipse around the nipple-areola complex or, preferably, as part of an inverted "T"-shaped incision, commonly used in reduction mammoplasty. This procedure adheres to oncological principles of skin-conserving mastectomy and also incorporates a lower dermal flap, used to create a dermo-muscular pocket that reinforces the coverage of the prosthetic implant.

The primary indication for mastectomy skin reducing is when a patient has excessively large (hypertrophic) and sagging (ptotic) breasts. In these cases, removing excess skin and breast tissue during mastectomy contributes to creating a solid foundation for breast reconstruction and improving the aesthetics of the reconstructed breast.

The purpose of this retrospective study is to provide accurate data on the clinical outcomes of mastectomy skin reducing performed at the European Oncology Institute in Milan. This study is part of a larger project involving patients with breast cancer and/or carriers of mutations in the Breast Cancer genes who have undergone mastectomy skin reducing in the last 5 years.

详细描述

It is a single-center study, conducted exclusively at the European Oncology Institute ( IEO). It is a retrospective study, analyzing events that occurred in the past. The results of this study, aggregating data from numerous patients, could influence public health policies by improving the efficiency and effectiveness of surgical treatments for patients with breast cancer and/or carriers of Breast Cancers mutations.

The study is independent and non-profit, conducted by a group with no financial interests, and will collect, in addition to genetic data, clinical and pathological information (related to the disease), information on the types of treatments performed, the presence or absence of recurrences or other tumors, and the survival status of patients.

IEO patient data will be transferred in anonymized form (the Oxford group cannot identify patients; only IEO can identify them) using a secure transmission channel. The study has been evaluated and authorized by an independent "Data Governance Board for Retrospective Studies at IEO" considering the scientific relevance of the study and its partners, relevance to the Institute's research lines, and the risk-benefit ratio from scientific, ethical-moral, and personal data protection perspectives.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • breast cancer affected women with moderate-large Breast underwent to skin reducing mastectomy.
  • High risk breast cancer ( BRCA1 and/or 2 mutated) women with moderate-large Breast underwent to skin reducing mastectomy.

排除标准

  • 未提供

结局指标

主要结局

rate of long term complications

时间窗: 60 months

Seroma, Infections, Necrosis, Prothesis Explantations,prothesis exposure

rate of short term complications

时间窗: 60 months

hematoma, seroma, bleeding, infections, necrosis, prothesis exposure,Prothesis Explantations

次要结局

  • rate of refinements(60 months)

研究者

发起方
European Institute of Oncology
申办方类型
Other
责任方
Sponsor

研究点 (1)

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