Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT04783818
Status:
COMPLETED
Last Update Posted:
2021-03-09
First Post:
2021-03-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adjuvant Radiotherapy's Effect on One and Two Stages Prosthetic Breast Reconstruction and on Autologous Reconstruction
Sponsor:
Humanitas Clinical and Research Center
Organization:
Study Overview
Official Title:
Multicenter Retrospective Evaluation Study of the Adjuvant Radiotherapy's Effect on One and Two Stages Prosthetic Breast Reconstruction and on Autologous Reconstruction
Status:
COMPLETED
Status Verified Date:
2021-03
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:
None
Brief Summary:
For patients with breast cancer subject to a mastectomy, preserving the morphology of the breast with immediate reconstruction is a crucial aspect to preserve the quality of life.
There are several types of breast reconstruction: prosthetic in one or two stages and autologous reconstruction.
Adjuvant radiotherapy has shown an improvement of the overall survival and of the local control for patients with positive lymph nodes.
Despite the undoubted cancer benefits, several studies have shown the negative impact of radiotherapy on breast reconstruction.
However, there are few studies with a significant number that evaluate the effect of radiotherapy on the three types of reconstruction.
In particular, given the extreme variability in clinical approaches, there is no certainty about the best reconstructive timing compared to radiotherapy, the iterations with dermic matrices as well as the usefulness of ancillary procedures such as autologous adipose grafting.
The aim of this study is to compare retrospectively these three types of reconstruction techniques to evaluate the effect of radiotherapy on different reconstructive modes.
There are several types of breast reconstruction: prosthetic in one or two stages and autologous reconstruction.
Adjuvant radiotherapy has shown an improvement of the overall survival and of the local control for patients with positive lymph nodes.
Despite the undoubted cancer benefits, several studies have shown the negative impact of radiotherapy on breast reconstruction.
However, there are few studies with a significant number that evaluate the effect of radiotherapy on the three types of reconstruction.
In particular, given the extreme variability in clinical approaches, there is no certainty about the best reconstructive timing compared to radiotherapy, the iterations with dermic matrices as well as the usefulness of ancillary procedures such as autologous adipose grafting.
The aim of this study is to compare retrospectively these three types of reconstruction techniques to evaluate the effect of radiotherapy on different reconstructive modes.
Detailed Description:
None
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?: