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A randomized clinical trial with two arms: irradiated women and non-irradiated women. Irradiated women are randomized to reconstruction with a latissimus Dorsi flap and an implant or a deep inferior epigastria perforator flap. Non-irradiated women are randomized to reconstruction with a thoracodorsal flap with an implant or with an expander and later a permanent implant in two stages.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Irradiated women | Other | Irradiated women are randomized to reconstruction with a latissimus Dorsi flap and an implant or a deep inferior epigastria perforator flap. |
|
| Non-irradiated women | Other | Non-irradiated women are randomized to reconstruction with a thoracodorsal flap with an implant or with an expander and later a permanent implant in two stages. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breast reconstruction | Procedure | Irradiated women are randomized to reconstruction with a latissimus Dorsi flap and an implant or a deep inferior epigastria perforator flap. Non-irradiated women are randomized to reconstruction with a thoracodorsal flap with an implant or with an expander and later a permanent implant in two stages. |
| Measure | Description | Time Frame |
|---|---|---|
| Aesthetic outcome | Photo evaluations | 1 year post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Breast related quality of life and satisfaction | Breast-q. Measures breast related quality of life on a scale 1-100. A higher score indicates a higher quality of life. | Pre-operatively and 3 years post-operatively |
| General quality of life measurement used for health economics |
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Irradiated patients:
Inclusion Criteria:
Exclusion Criteria:
Non-irradiated patients
Inclusion Criteria:
->18 years of age
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32807615 | Result | Brorson F, Thorarinsson A, Kolby L, Elander A, Hansson E. Early complications in delayed breast reconstruction: A prospective, randomized study comparing different reconstructive methods in radiated and non-radiated patients. Eur J Surg Oncol. 2020 Dec;46(12):2208-2217. doi: 10.1016/j.ejso.2020.07.010. Epub 2020 Jul 26. | |
| 36210311 |
| Label | URL |
|---|---|
| Research group | View source |
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| ID | Term |
|---|---|
| D016462 | Mammaplasty |
| ID | Term |
|---|---|
| D003357 | Cosmetic Techniques |
| D013812 | Therapeutics |
| D019651 | Plastic Surgery Procedures |
| D013514 | Surgical Procedures, Operative |
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|
EuroQol-5 domensions-3 levels is a generic instrument developed for health economic and clinical evaluation of healthcare. A total score between 0 and 1 is calculated. Zero equals death and 1 perfect health. |
| Pre-operatively and 3 years post-operatively |
| Depression | Beck Depression Inventory (BDI 21) for mood assessment. Scale range is 0-63 and higher scores indicate worse outcome. | Pre-operatively and 3 years post-operatively |
| General quality of life | Short form health survey (SF-36). The scale ranges from 0 to 100 and a higher score indicates a better quality of life. | Pre-operatively and 3 years post-operatively |
| Early complication frequency | Complications described according to Clavien-Dindo | 2 weeks post-operatively |
| Long-term complications | Re-operations and corrections | Five years post-operatively |
| Health economics | Costs of different procedures | Five years post-operatively |
| Implant survival (Ancillary study) | Analysis of number of implants removed over time (Ethical permit: 2021-06131-02) | 19 years |
| Brorson F, Elander A, Thorarinsson A, Hansson E. Patient Reported Outcome and Quality of Life After Delayed Breast Reconstruction - An RCT Comparing Different Reconstructive Methods in Radiated and Non-radiated Patients. Clin Breast Cancer. 2022 Dec;22(8):753-761. doi: 10.1016/j.clbc.2022.09.004. Epub 2022 Sep 17. |
| 28861376 | Result | Thorarinsson A, Frojd V, Kolby L, Liden M, Elander A, Mark H. Patient determinants as independent risk factors for postoperative complications of breast reconstruction. Gland Surg. 2017 Aug;6(4):355-367. doi: 10.21037/gs.2017.04.04. |
| 28740762 | Result | Thorarinsson A, Frojd V, Kolby L, Ljungdal J, Taft C, Mark H. Long-Term Health-Related Quality of Life after Breast Reconstruction: Comparing 4 Different Methods of Reconstruction. Plast Reconstr Surg Glob Open. 2017 Jun 21;5(6):e1316. doi: 10.1097/GOX.0000000000001316. eCollection 2017 Jun. |
| 28122466 | Result | Thorarinsson A, Frojd V, Kolby L, Modin A, Lewin R, Elander A, Mark H. Blood loss and duration of surgery are independent risk factors for complications after breast reconstruction. J Plast Surg Hand Surg. 2017 Oct;51(5):352-357. doi: 10.1080/2000656X.2016.1272462. Epub 2017 Jan 26. |
| 26360138 | Result | Thorarinsson A, Frojd V, Kolby L, Lewin R, Molinder N, Lundberg J, Elander A, Mark H. A retrospective review of the incidence of various complications in different delayed breast reconstruction methods. J Plast Surg Hand Surg. 2016;50(1):25-34. doi: 10.3109/2000656X.2015.1066683. Epub 2015 Sep 11. |