Prosthetic Breast Reconstruction After Mastectomy

Recruiting now

Conditions studied: Breast Reconstruction

In brief

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

Key facts

Study ID

NCT06774352

Run by

IRCCS Azienda Ospedaliero-Universitaria di Bologna

People needed

200

Starts

2011-01-01

Expected to finish

2027-01-01

Last updated by the study team

2025-01-14

Who can join

Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Sex F
• Patients undergoing mastectomy (R-m, SS-m, NSS-m)
• Age 18 - 70
• Prosthetic breast reconstruction (DTI or EXP-IMPL)
• Written informed consent

You may not qualify if…

• Autologous breast reconstruction

Where it is running

• IRCCS AOU di Bologna Policlinico di Sant'Orsola — Bologna, Italy (enrolling)

Full record on ClinicalTrials.gov

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