RecruitingNCT05817175

International Prospective REgistry on Pre-pectorAl Breast REconstruction


Sponsor

IRCCS San Raffaele

Enrollment

1,236 participants

Start Date

Sep 12, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This registry tracks outcomes for women who have had breast reconstruction surgery using implants placed in front of the chest muscle (pre-pectoral reconstruction) after mastectomy. Researchers want to understand how well this newer surgical approach works compared to placing implants behind the muscle. **You may be eligible if...** - You are a woman over 18 years old - You have had or are having a mastectomy (full breast removal) - You are having breast reconstruction using an implant or tissue expander placed in front of the chest muscle (pre-pectoral placement), with or without a supportive mesh **You may NOT be eligible if...** - You are male - You are having reconstruction using your own body tissue (autologous reconstruction) - You are having reconstruction with the implant placed behind the chest muscle (subpectoral) - You are not suitable for surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREpre-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


Locations(11)

Univesidad de Buenos Aires

Buenos Aires, Argentina

Mansoura Insurance

Al Mansurah, Egypt

Mansoura Oncology

Al Mansurah, Egypt

National ans Kapodistrian University of Athens

Athens, Greece

Ospedale San Raffaele

Milan, MI, Italy

Fondazione Policlinico Universitario Agostino Gemelli

Roma, RM, Italy

University Hospital of Karol Marcinkowski

Zielona Góra, Poland

Prof. Dr. Ion Chiricuta Institute of Oncology

Cluj-Napoca, Romania

Hospital del Mar

Barcelona, Spain

Marmara University School of medicine

Istanbul, Turkey (Türkiye)

University Hospitals of Leicester

Leicester, United Kingdom

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NCT05817175


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