Prosthetic Breast Reconstruction After Mastectomy (BrREC2020)

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Enrolling

Conditions: Breast Reconstruction

Study type: Observational

Funder types: Other

Identifiers

NCT06774352

BrREC2020

Details and patient eligibility

About

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

Full 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

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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 criteria

• Autologous breast reconstruction

Trial design

200 participants in 1 patient group

Prosthetic breast reconstruction (DTI or EXP-IMPL)

Description:

immediate prosthetic breast reconstructions (DTI - Direct to Implant) and in two surgical stages (EXP-IMPL - expander/prosthesis), after mastectomy