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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05817175
Other study ID # EUBREAST-11R
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 16, 2023
Est. completion date September 10, 2027

Study information

Verified date May 2024
Source IRCCS San Raffaele
Contact Oreste D Gentilini, Dr
Phone +390226431
Email gentilini@eubreast.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1236
Est. completion date September 10, 2027
Est. primary completion date September 10, 2027
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Argentina Univesidad de Buenos Aires Buenos Aires
Egypt Mansoura Insurance Mansoura
Egypt Mansoura Oncology Mansoura
Greece National ans Kapodistrian University of Athens Athens
Italy Ospedale San Raffaele Milano MI
Italy Fondazione Policlinico Universitario Agostino Gemelli Roma RM
Poland University Hospital of Karol Marcinkowski Zielona Góra
Romania Prof. Dr. Ion Chiricuta Institute of Oncology Cluj-Napoca
Spain Hospital del Mar Barcelona
Turkey Marmara University School of medicine Istanbul
United Kingdom University Hospitals of Leicester Leicester

Sponsors (2)

Lead Sponsor Collaborator
IRCCS San Raffaele EUBREAST ETS

Countries where clinical trial is conducted

Argentina,  Egypt,  Greece,  Italy,  Poland,  Romania,  Spain,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients with Implant-loss at three months postoperatively Rate of implant-loss at three months postoperatively defined as the unplanned removal or loss of the implant as a result of infection or other complication three months postoperatively
Secondary Number of patients with Infection Rate of infection defined as minor if oral antibiotic was required, major if surgical revision and/or hospitalisation was necessary; three months postoperatively
Secondary Number of patients with re-admission and re-operation Rate of re-admission and re-operation three months postoperatively
Secondary Evaluation of Quality of life Patient's satisfaction and quaity of life measured through BREASTQ (Breast Reconstruction Module Questionnaire) 0, 6, 12 and 24 months
Secondary Number of Early onset complication Early onset complication at 3 month follow up: seroma, hematoma/bleeding, skin flap or T junction necrosis, nipple necrosis, wound dehiscence, implant malposition (i.e. rotation, displacement etc..), red-breast syndrome three months postoperatively
Secondary Number of late-onset complications seroma, capsular contracture, wrinkling/rippling, implant malposition (i.e. rotation, displacement etc..) implant upper pole visibility, implant loss; 6-12-24 months
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