Prosthetic Breast Reconstruction After Mastectomy

Recruiting

• Conditions: Breast Reconstruction

• Registration Number: NCT06774352
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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

Study Timeline

• Study Start: 2011-01-01
• Status Verified: 2024-12
• Study First Submitted: 2025-01-09
• Study First Submitted QC: 2025-01-09
• Last Update Submitted: 2025-01-09
• Study First Posted: 2025-01-14
• Last Update Posted: 2025-01-14
• Primary Completion: 2027-01-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

IRCCS AOU di Bologna Policlinico di Sant'Orsola; 🇮🇹 Bologna, Italy