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Breast Reconstruction in Previously Irradiated Breast

H

Humanitas Clinical and Research Center

Status

Completed

Conditions

Breast Implant; Complications
Mammaplasty
Radiotherapy; Complications
Transplant Failure

Treatments

Radiation: Pre reconstruction Radiotherapy

Study type

Observational

Funder types

Other

Identifiers

NCT04854525
49/20 b

Details and patient eligibility

About

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.

Enrollment

2,150 patients

Sex

Female

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients subjected to mastectomy and immediate reconstruction directly with prostheses, in two times and by autologue flaps (TRAM, Latissimus Dorsi Flap, DIEP and any other method)

Exclusion criteria

  • Delayed prosthetic reconstruction

Trial design

2,150 participants in 6 patient groups

One Stage Reconstruction With pre-reconstruction Radiotherapy
Treatment:
Radiation: Pre reconstruction Radiotherapy
Two Stage Reconstruction With pre-reconstruction Radiotherapy
Treatment:
Radiation: Pre reconstruction Radiotherapy
Autologous Reconstruction With pre-reconstruction Radiotherapy
Treatment:
Radiation: Pre reconstruction Radiotherapy
One Stage Reconstruction Without pre-reconstruction Radiotherapy
Two Stage Reconstruction Without pre-reconstruction Radiotherapy
Autologous Reconstruction Without pre-reconstruction Radiotherapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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