International Prospective REgistry on Pre-pectorAl Breast REconstruction

Study Overview
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Brief Summary
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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
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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.

Official Title
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International Prospective REgistry on Pre-pectorAl Breast REconstruction

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: pre-pectoral breast reconstruction


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Number of patients with re-admission and re-operation | Rate of re-admission and re-operation | three months postoperatively | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Breast reconstruction, Pre-pectoral Breast Prosthesis, Mastectomy