Prosthetic Breast Reconstruction After Mastectomy

NCT06774352 | Recruiting

• 1 other identifier: BrREC2020
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Reconstruction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient satisfaction

  From the first patient enrolled, up to the 200th. An average of 2 years

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Sex F
• Patients undergoing mastectomy (R-m, SS-m, NSS-m)
• Age 18 - 70
• Prosthetic breast reconstruction (DTI or EXP-IMPL)
• Written informed consent

You may not qualify if:

• Autologous breast reconstruction

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS AOU di Bologna Policlinico di Sant'Orsola

Bologna, 40138, Italy

RECRUITING

Study Officials

• Valentina Pinto, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Pignatti, MD

CONTACT

+39 051 2143614; marco.pignatti@unibo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 14, 2025
• Study Start: January 1, 2011
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 14, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)