NCT04854525

Breast Reconstruction in Previously Irradiated Breast

Multicenter Retrospective Evaluation Study of Pre-reconstruction Radiotherapy's Effect on One and Two Stages Prosthetic Breast Reconstruction and on Autologous Reconstruction

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,150 (actual)
• Sponsor: Humanitas Clinical and Research Center · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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. As a consequence, plastic surgeons come into contact with more patients with a history of irradiation of their breasts than ever before. However, there are few studies with a significant number that evaluate the effect of pre-reconstruction radiotherapy on the three types of reconstruction. The aim of this study is to compare retrospectively these three types of reconstruction techniques to evaluate the impact of breast prior irradiation on the outcome of prosthetic reconstruction.

Conditions

• Mammaplasty
• Radiotherapy; Complications
• Breast Implant; Complications
• Transplant Failure

Interventions

Type	Name	Description
RADIATION	Pre reconstruction Radiotherapy	Previous PMRT

Timeline

• Start date: 2020-06-06
• Primary completion: 2020-11-23
• Completion: 2021-01-25
• First posted: 2021-04-22
• Last updated: 2021-04-22

Locations

1 site across 1 country: Italy