Prosthetic Breast Reconstruction After Mastectomy

Last updated: January 9, 2025
Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Reconstruction

Treatment

N/A

Clinical Study ID

NCT06774352
BrREC2020
  • Ages 18-70
  • Female

Study Summary

Breast cancer represents a disabling diagnosis for women, and the related destructive surgical intervention of mastectomy inevitably affects their social, relational and working life. The primary aim of post-oncological breast reconstruction is to restore volume, shape and projection as similar as possible to the contralateral breast, in unilateral mastectomies and between the two reconstructed breasts, in bilateral mastectomies, avoiding the patient the need to resort to uncomfortable and unsightly external prostheses.

The study in question has a purely observational and non-interventional nature, in order to evaluate whether today the traditional EXP-IMPL prosthetic reconstructive technique represents an obsolete option or whether it can still be considered a valid alternative in clinical, anthropometric and patient satisfaction terms

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Sex F

  • Patients undergoing mastectomy (R-m, SS-m, NSS-m)

  • Age 18 - 70

  • Prosthetic breast reconstruction (DTI or EXP-IMPL)

  • Written informed consent

Exclusion

Exclusion Criteria:

  • Autologous breast reconstruction

Study Design

Total Participants: 200
Study Start date:
January 01, 2011
Estimated Completion Date:
January 01, 2027

Study Description

The primary aim of post-oncological breast reconstruction is to restore volume, shape and projection as similar as possible to the contralateral breast, in unilateral mastectomies and between the two reconstructed breasts, in bilateral mastectomies, avoiding the patient the need to resort to uncomfortable and unexpectedly external prostheses.

The study in question has a purely observational and non-interventional nature, in order to evaluate whether today the traditional EXP-IMPL prosthetic reconstructive technique represents an obsolete option or whether it can still be considered a valid alternative in clinical, anthropometric and patient satisfaction terms. In order to evaluate outcomes in prosthetic breast reconstructions immediate (DTI - Direct to Implant) and in two surgical stages (EXP-IMPL - expander/prosthesis), after mastectomy, the aforementioned data will be subjected to appropriate statistical analysis

Connect with a study center

  • IRCCS AOU di Bologna Policlinico di Sant'Orsola

    Bologna, 40138
    Italy

    Active - Recruiting

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