Clinical trial NCT06774352: Prosthetic Breast Reconstruction After Mastectomy
Official title: Prosthetic Breast Reconstruction After Mastectomy: Comparison of Clinical, Anthropometric and Patient Satisfaction Parameters
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Reconstruction
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-14
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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

Eligibility criteria: 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 outcomes:
measure: Technical Success
timeFrame: From the first patient entrolled, up to the 200th patient, an average of 2 years
Secondary outcomes:
measure: Patient satisfaction
timeFrame: From the first patient enrolled, up to the 200th. An average of 2 years
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS AOU di Bologna Policlinico di Sant'Orsola
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Valentina Pinto, MD
role: PRINCIPAL_INVESTIGATOR
References: