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| Name | Class |
|---|---|
| EUBREAST ETS | UNKNOWN |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pre-pectoral breast reconstruction | Procedure | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Female patients older than 18 years old
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All patients who are candidates for implant-based reconstruction should be informed about the possible participation to this clinical study. The inclusion and exclusion criteria are verified by the investigator and an informed consent is obtained from the patient.
The therapeutic pattern should be followed according to institutional and national standards. Since this is a non-interventional trial, the study sites do not deviate from their own study protocol at any timepoint.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oreste D Gentilini, Dr | Contact | +390226431 | 3939 | gentilini@eubreast.com |
| Rosa Di Micco, Dr | Contact | +390226431 | 4565 | dimicco.rosa@hsr.it |
| Name | Affiliation | Role |
|---|---|---|
| Oreste D Gentilini, Dr | IRCCS San Raffaele | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univesidad de Buenos Aires | Recruiting | Buenos Aires | Argentina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42383235 | Derived | Di Micco R, Scardina L, Botteri E, Banys-Paluchowski M, Cardoso MJ, de Boniface J, Gasparri ML, Gulluoglu BM, Kaidar-Person O, Nava MB, Poortmans P, Potter S, Rocco N, Spanic T, Thill M, Travado L, Veselinovic K, Weber WP, Zuber V, Cisternino G, Baleri S, Rampa M, Corona SP, Calabretto F, Ceccarino R, Rottino A, Franceschini G, Kuhn T, Gentilini OD; I-PREPARE Study Group. Pre-Pectoral Breast Reconstruction after Mastectomy: Current Evidence, Knowledge Gaps, and Rationale for the I-PREPARE EUBREAST-11R Trial. Breast Care (Basel). 2026 Jun 5. doi: 10.1159/000551101. Online ahead of print. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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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 |
| Mansoura Insurance | Recruiting | Al Mansurah | Egypt |
|
| Mansoura Oncology | Recruiting | Al Mansurah | Egypt |
|
| National ans Kapodistrian University of Athens | Recruiting | Athens | Greece |
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| Ospedale San Raffaele | Recruiting | Milan | MI | 20132 | Italy |
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| Fondazione Policlinico Universitario Agostino Gemelli | Recruiting | Roma | RM | 00136 | Italy |
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| University Hospital of Karol Marcinkowski | Recruiting | Zielona Góra | Poland |
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| Prof. Dr. Ion Chiricuta Institute of Oncology | Recruiting | Cluj-Napoca | Romania |
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| Hospital del Mar | Recruiting | Barcelona | Spain |
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| Marmara University School of medicine | Recruiting | Istanbul | Turkey (Türkiye) |
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| University Hospitals of Leicester | Recruiting | Leicester | United Kingdom |
|
| D017437 |
| Skin and Connective Tissue Diseases |