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Completed

NCT Number: NCT04783818

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

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.

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Key information

Conditions

Mammaplasty Breast Implant; Complications Radiotherapy; Complications Transplant Failure

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

Istituto Clinico Humanitas

Rozzano, Milan, 20089, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adjuvant radiotherapy

Radiation

PMRT

Primary outcomes

  1. Reconstruction failure

    Time frame: 2 years

    Complication rate (as hematoma, seroma, prosthetic exposure, skin and fat necrosis) that resulted in explant (prosthetic, expander or flap)

Secondary outcomes

  1. Reconstruction Complications

    Time frame: 2 years

    Rate of capsular contracture and rate of need for reintervention

Sponsors and collaborators

Lead sponsor

Humanitas Clinical and Research Center

Other

Collaborators

  • Davide Franceschini
  • Emanuela Morenghi
  • Marco Klinger
  • Marta Scorsetti

Registry information

Official study title

Multicenter Retrospective Evaluation Study of the Adjuvant Radiotherapy's Effect on One and Two Stages Prosthetic Breast Reconstruction and on Autologous Reconstruction

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Mar 5, 2021
Registry last updated
Mar 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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