Prosthetic Breast Reconstruction After Mastectomy

Prosthetic Breast Reconstruction After Mastectomy: Comparison of Clinical, Anthropometric and Patient Satisfaction Parameters

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06774352

Acronym

BrREC2020

Enrollment

200

Registered

2025-01-14

Start date

2011-01-01

Completion date

2027-01-01

Last updated

2025-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Reconstruction

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Secondary

Measure	Time frame	Description
Patient satisfaction	From the first patient enrolled, up to the 200th. An average of 2 years	Satisfaction is measured by specific Q-Breast questionnaire

Countries

Italy

Contacts

Primary ContactMarco Pignatti, MD

marco.pignatti@unibo.it+39 051 2143614

Outcome results