International Prospective REgistry on Pre-pectorAl Breast REconstruction (I-PREPARE)

San Donato Group (GSD)

Status: Enrolling

Conditions: Breast Cancer

Treatments: Procedure: pre-pectoral breast reconstruction

Study type: Observational

Funder types: Other

Identifiers

NCT05817175

EUBREAST-11R

Details and patient eligibility

About

This is an international multicenter prospective cohort study aimed at collecting data on breast reconstruction techniques with pre-pectoral implants after mastectomy for breast cancer. The aim of the study is to collect data on the surgical, aesthetic and oncological results, as well as on the quality of life of the patients who will undergo breast reconstruction with a pre-pectoral approach.

Full description

1,236 patients undergoing mastectomy for breast cancer and subsequent pre-pectoral breast reconstruction will be enrolled. Being an observational study, the diagnostic-therapeutic path of the patients will not be modified in any way. Therefore, no risks are anticipated for the patients who will participate in this study. Potential benefits deriving from the study will be for future patients for whom good quality data will be available which can guide the choice of the type of breast reconstruction to be performed, in particular the most appropriate type of technique in the pre-pectoral approach.

Enrollment: 1,236 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female patients older than 18 years old
• Signed informed consent form
• Patients undergoing mono or bilateral therapeutic mastectomy
• Patients undergoing pre-pectoral implant-based breast reconstruction with implant or expander with or without mesh

Exclusion criteria

• Male patients
• Patients not suitable for surgical treatment
• Patients undergoing subpectoral reconstruction
• Patients undergoing breast reconstruction with autologous tissue.