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Adjuvant Radiotherapy's Effect on One and Two Stages Prosthetic Breast Reconstruction and on Autologous Reconstruction

H

Humanitas Clinical and Research Center

Status

Completed

Conditions

Breast Implant; Complications
Mammaplasty
Radiotherapy; Complications
Transplant Failure

Treatments

Radiation: Adjuvant Radiotherapy

Study type

Observational

Funder types

Other

Identifiers

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.

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.

Enrollment

3,200 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

3,200 participants in 6 patient groups

One Stage Reconstruction With Adjuvant Radiotherapy
Treatment:
Radiation: Adjuvant Radiotherapy
Two Stage Reconstruction With Adjuvant Radiotherapy
Treatment:
Radiation: Adjuvant Radiotherapy
Autologous Reconstruction With Adjuvant Radiotherapy
Treatment:
Radiation: Adjuvant Radiotherapy
One Stage Reconstruction Without Adjuvant Radiotherapy
Two Stage Reconstruction Without Adjuvant Radiotherapy
Autologous Reconstruction Without Adjuvant Radiotherapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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