Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06133452
Status:
COMPLETED
Last Update Posted:
2023-12-21
First Post:
2023-11-10
Brief Title:
Clinical Outcomes of Patients Undergoing Skin-Reducing Mastectomies
Sponsor:
European Institute of Oncology
Organization:
European Institute of Oncology
Study Overview
Official Title:
Clinical Outcomes of Patients Undergoing Skin-Reducing Mastectomies A Long-Term Retrospective Study
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SRM
Brief Summary:
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 andor 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 andor carriers of mutations in the Breast Cancer genes who have undergone mastectomy skin reducing in the last 5 years
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 andor carriers of mutations in the Breast Cancer genes who have undergone mastectomy skin reducing in the last 5 years
Detailed Description:
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 andor 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 Institutes research lines and the risk-benefit ratio from scientific ethical-moral and personal data protection perspectives
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 Institutes research lines and the risk-benefit ratio from scientific ethical-moral and personal data protection perspectives
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None