Breast Cancer
Conditions
Keywords
Breast Cancer, Breast reconstruction, Pre-pectoral Breast Prosthesis, Mastectomy
Brief 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.
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
Sponsors
European Breast Cancer Research Association of Surgical Trialists
EUBREAST ETS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with Implant-loss at three months postoperatively | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with Infection | three months postoperatively | Rate of infection defined as minor if oral antibiotic was required, major if surgical revision and/or hospitalisation was necessary; |
| Number of patients with re-admission and re-operation | three months postoperatively | Rate of re-admission and re-operation |
| Evaluation of Quality of life | 0, 6, 12 and 24 months | Patient's satisfaction and quaity of life measured through BREASTQ (Breast Reconstruction Module Questionnaire) |
| Number of Early onset complication | three months postoperatively | 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 |
| Number of late-onset complications | 6-12-24 months | seroma, capsular contracture, wrinkling/rippling, implant malposition (i.e. rotation, displacement etc..) implant upper pole visibility, implant loss; |
Countries
Argentina, Egypt, Greece, Italy, Poland, Romania, Spain, Turkey (Türkiye), United Kingdom
Contacts
CONTACTOreste D Gentilini, Dr
CONTACTRosa Di Micco, Dr
STUDY_CHAIROreste D Gentilini, Dr
IRCCS San Raffaele
Outcome results
None listed