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| Name | Class |
|---|---|
| Danish Cancer Society | OTHER |
| The Korning foundation | UNKNOWN |
| Foundation of the Kjaersgaard Family | UNKNOWN |
| King Christian X foundation |
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The aim of this study is to contribute to the knowledge regarding immediate implant-based BR by investigating whether the one-stage technique with ADM is superior to the two-stage expander to implant technique. Primary endpoint in first publication is postoperative complications, secondary endpoint is patient and investigator assessed aesthetic outcome. Primary endpoint in second publication is cost, secondary endpoint is patient reported outcome measures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One-stage group | Immediate implant based breast reconstruction after skin sparing mastectomy in one stage using silicone implant and acellular dermal matrix. |
| |
| Two-stage group | Immediate implant based breast reconstruction after skin sparing mastectomy in two stages using expander to silicone implant technique. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| one-stage technique | Procedure | breast reconstruction in one stage using silicone implant and acellular dermal matrix. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative complications | Major (requiring surgery - infection, hematoma, mastectomy flap necrosis). Obtained by review of patient chart. | 3 months |
| Postoperative complications | Minor (not requiring surgery - seroma, cellulitis). Obtained by review of patient chart. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient assessed satisfaction with aesthetic result | Assessment of result with and without clothes, symmetry and all-in-all satisfaction with result. Obtained by questionnaire on a 7 point Likert scale. Higher score equals higher satisfaction. | 2 years |
| Investigator assessed satisfaction with aesthetic result |
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Inclusion Criteria:
Exclusion Criteria:
- smokers
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Eligible patients were all women admitted for immediate, implant-based breast reconstruction following skin-sparing mastectomy at the Department of Plastic and Breast Surgery, Aarhus University Hospital, Denmark from September 2010 to January 2014.
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| Name | Affiliation | Role |
|---|---|---|
| Mette Eline Brunbjerg, MD | Aarhus University Hospital, Aarhus University, Denmark | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33633977 | Derived | Brunbjerg ME, Jensen TB, Overgaard J, Christiansen P, Damsgaard TE. Comparison of one-stage direct-to-implant with acellular dermal matrix and two-stage immediate implant-based breast reconstruction-a cohort study. Gland Surg. 2021 Jan;10(1):207-218. doi: 10.21037/gs-20-581. |
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All data will be anonymized.
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D000071960 | Breast Carcinoma In Situ |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| UNKNOWN |
| Foundation of architect Holger Hjortenberg | UNKNOWN |
| LifeCell Corporation (Branchburg, NJ, USA) | UNKNOWN |
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Assessment of result with and without clothes, symmetry (including measurements of sternal notch-papil distance and papilla-inframammary fold distance). Obtained by clinical examination. |
| 2 years |
| Patient reported outcome measures | Patient reported assessment of pain and dysaesthesia in reconstructed breast, arm/shoulder function on reconstructed side. Described on a 6 point scale where lower score equals more pain/dysaesthesia/troubles with arm/shoulder function. Body image (Hopwoods Body Image Scale) assessed in a 10-items each on 4 point Likert scale from 0 to 3. Sum provides a total score (range 0-30) and lower scores equals less body image troubles. Furthermore, study specific questions as "use of pain killers the last week" (yes / no) and "all in all assessment of health owning to the breast reconstruction" (improved / diminished or unchanged). All obtained by questionnaire. | 2 years |
| Cost | cost analysis comparing the two methods regarding hospitalization, out patient visits, cost of expander/implant/acellular dermal matrix, surgical interventions. | 2 years |
| D017437 |
| Skin and Connective Tissue Diseases |
| D002278 | Carcinoma in Situ |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |