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Actively Recruiting

Age: 18Years +
FEMALE
ID05817175

International Study on Pre-pectoral Breast Reconstruction After Mastectomy for Breast Cancer

Led by IRCCS San Raffaele · Updated on 2025-06-04

1236

Participants Needed

11

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are conducting an international multicenter prospective cohort study to gather information on breast reconstruction techniques using pre-pectoral implants after mastectomy for breast cancer. This observational study aims to collect data on surgical, aesthetic, and cancer-related outcomes, along with patients quality of life following this type of reconstruction. The study will include 1,236 female patients undergoing mastectomy for breast cancer followed by pre-pectoral implant-based breast reconstruction, which may involve implants or expanders with or without mesh. Since this is an observational study, patients medical and surgical care will not be altered, and no additional risks are expected. The research will evaluate the use of the pre-pectoral approach, including outcomes related to different surgical techniques and the impact of postmastectomy radiation therapy. Participants will be followed to assess outcomes such as implant loss, infections, readmissions, re-operations, and complications at various time points, including three months and up to 24 months after surgery. Quality of life will be evaluated at 0, 6, 12, and 24 months. The study will provide valuable data to guide future breast reconstruction decisions while keeping patient safety and well-being a priority.

CONDITIONS

Brief Title

International Prospective REgistry on Pre-pectorAl Breast REconstruction

Research Team

O

Oreste D Gentilini, Dr

R

Rosa Di Micco, Dr

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