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OpenTrials
Completed

NCT Number: NCT04854525

Breast Reconstruction in Previously Irradiated Breast

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.

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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

Pre reconstruction Radiotherapy

Radiation

Previous 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 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 Pre-reconstruction 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
Apr 22, 2021
Registry last updated
Apr 22, 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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