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Recruiting Observational

Prosthetic Breast Reconstruction After Mastectomy

NCT06774352 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2011-01-01
Last updated
2025-01-14

Condition(s) studied

Breast Reconstruction

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

Sex
FEMALE
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Technical Success — From the first patient entrolled, up to the 200th patient, an average of 2 years
    Technical Success is defined by number of reinterveions, major complication and the necessity to change approach.

Trial sites (1)

FacilityCityRegionStatus
IRCCS AOU di Bologna Policlinico di Sant'Orsola Bologna Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06774352 on ClinicalTrials.gov ↗ ← All trials in Italy