NCT05817175

International Prospective REgistry on Pre-pectorAl Breast REconstruction

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,236 (estimated)
• Sponsor: IRCCS San Raffaele · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	pre-pectoral breast reconstruction	to prospectively evaluate the utilization of the pre-pectoral approach, and evaluate oncological and aesthetic outcomes related to each type of surgical technique and the use of postmastectomy radiation therapy

Timeline

• Start date: 2023-09-12
• Primary completion: 2027-09-10
• Completion: 2027-09-10
• First posted: 2023-04-18
• Last updated: 2025-06-04

Locations

11 sites across 9 countries: Argentina, Egypt, Greece, Italy, Poland, Romania, Spain, Turkey (Türkiye), United Kingdom