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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-A01369-34 | Registry Identifier | RCB |
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autorities vorbidden this dispositif in other trial
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The purpose of this study is to study the impact of the immediate implant breast reconstruction for patients with mastectomy and postoperative chest wall radiotherapy
non applicable
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| immediate implant breast reconstruction | Experimental | immediate implant breast reconstruction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| immediate implant breast reconstruction | Procedure | Eligible patients will undergo radical mastectomy with axillary lymph nodes sampling followed by immediate and single-stage breast reconstruction using the acellular dermal matrix Stratticeâ„¢ |
| Measure | Description | Time Frame |
|---|---|---|
| Success is defined as a complete therapeutic sequence (surgery + RT) without any significant complication at 6 months. | Success is defined as a complete therapeutic sequence (surgery + RT) without any significant complication at 6 months. Significant complication is defined as:
| confirm the feasibility of the therapeutic sequence at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of Baker | The rate of Baker grades 3/4 capsular contracture | up to 36 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Cosmetic results | Cosmetic results: assessed by both the surgeon and patient (patient satisfaction will be evaluated using a self-questionnaire). Photographs of the breast will be taken at different times (Pre / per / postoperative) and the picture analysis will be reviewed by an independent committee. | up to 36 months after surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut régional du Cancer - Montpellier - Val d'Aurelle | Montpellier | 34000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16432358 | Background | Christian CK, Niland J, Edge SB, Ottesen RA, Hughes ME, Theriault R, Wilson J, Hergrueter CA, Weeks JC. A multi-institutional analysis of the socioeconomic determinants of breast reconstruction: a study of the National Comprehensive Cancer Network. Ann Surg. 2006 Feb;243(2):241-9. doi: 10.1097/01.sla.0000197738.63512.23. | |
| 22296996 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 6, 2024 | |
| Reset | Oct 25, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 6, 2024 | Oct 25, 2024 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Functional results |
Functional results: patient satisfaction will be evaluated using a self-questionnaire |
| up to 36 months after surgery |
| The rate of patients requiring breast implant removal | The rate of patients requiring breast implant removal | up to 36 months after surgery |
| Study of tolerance | Study of the indesirable effect of the radiotherapy on the implant | up to 36 months after surgery |
| Lambert K, Mokbel K. Does post-mastectomy radiotherapy represent a contraindication to skin-sparing mastectomy and immediate reconstruction: an update. Surg Oncol. 2012 Jun;21(2):e67-74. doi: 10.1016/j.suronc.2011.12.007. Epub 2012 Jan 30. |
| D017437 |
| Skin and Connective Tissue Diseases |