Prosthetic Breast Reconstruction After Mastectomy: Comparison of Clinical, Anthropometric and Patient Satisfaction Parameters
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Reconstruction
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Technical Success
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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
Detailed 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
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Outcomes
Primary Outcomes
Technical Success
Time Frame: 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.
Secondary Outcomes
- Patient satisfaction(From the first patient enrolled, up to the 200th. An average of 2 years)