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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prosthetic breast reconstruction (DTI or EXP-IMPL) | immediate prosthetic breast reconstructions (DTI - Direct to Implant) and in two surgical stages (EXP-IMPL - expander/prosthesis), after mastectomy |
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| Measure | Description | Time Frame |
|---|---|---|
| Technical Success | Technical Success is defined by number of reinterveions, major complication and the necessity to change approach. | From the first patient entrolled, up to the 200th patient, an average of 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction | Satisfaction is measured by specific Q-Breast questionnaire | From the first patient enrolled, up to the 200th. An average of 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients, who underwent post-oncological prosthetic breast reconstruction in the period between 1.1.2011 - 31.5.2020, at the Plastic Surgery Unit of the University Hospital Company - Sant'Orsola Polyclinic - Bologna. The data recorded in the study derive from pre-operative and post-operative assessments, in accordance with daily clinical practice and normally performed for correct patient management.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marco Pignatti, MD | Contact | +39 051 2143614 | marco.pignatti@unibo.it |
| Name | Affiliation | Role |
|---|---|---|
| Valentina Pinto, MD | IRCCS Azienda Ospedaliero-Universitaria di Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS AOU di Bologna Policlinico di Sant'Orsola | Recruiting | Bologna | 40138 | Italy |
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