Prosthetic Breast Reconstruction After Mastectomy (BrREC2020)

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

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

Study Overview

• Status: Recruiting
• Conditions: Breast Reconstruction

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

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Marco Pignatti, MD; Phone Number: +39 051 2143614; Email: marco.pignatti@unibo.it

Study Locations

• Italy
  • Bologna, Italy, 40138
    • Recruiting
    • IRCCS AOU di Bologna Policlinico di Sant'Orsola
    • Contact: Marco Pignatti, MD; Phone Number: +39 051 2143614; Email: mauro.gargiulo2@unibo.it
    • Principal Investigator: Marco Pignatti, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Valentina Pinto, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2011
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: January 9, 2025
• First Submitted That Met QC Criteria: January 9, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 9, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: BrREC2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No