MedTrace Logo

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

NCT04783818 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3200

Last updated 2021-03-09

No results posted yet for this study

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.

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.

Conditions

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

Interventions

RADIATION

Adjuvant Radiotherapy

PMRT

Sponsors & Collaborators

  • Marco Klinger

    collaborator UNKNOWN

  • Marta Scorsetti

    collaborator UNKNOWN

  • Davide Franceschini

    collaborator UNKNOWN

  • Emanuela Morenghi

    collaborator UNKNOWN

  • Humanitas Clinical and Research Center

    lead OTHER

Principal Investigators

  • Marco Klinger · Humanitas Hospital, Italy

  • Davide Franceschini · Humanitas Hospital, Italy

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-06
Primary Completion
2020-11-23
Completion
2021-01-25

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04783818 on ClinicalTrials.gov