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Current literature on complications and health-related quality of life in autologous and alloplastic breast reconstruction is inconclusive. Despite the great demand for more in-depth, long-term studies of both techniques, current evidence is low or moderate and there are only few studies focusing on both health-related quality of life and complication rates in the same patient collective.
This study aims at investigating the complex relationship between the occurrence of complications and patient-reported long-time satisfaction in autologous and alloplastic breast reconstruction.
The study is conducted at the Medical University of Graz and has been approved by the responsible ethics' committee (EK: 32-235 ex 19/20). The study includes female breast cancer patients who underwent elective breast reconstruction at one of the participating departments between April 2020 and April 2023. Written informed consent was obtained from all individual study participants enrolled.
Exclusion criteria is defined as:
Data were first collected retrospectively from the clinical data management programs using surgical reports, outpatient charts, and physicians' letters. Personal data such as patient age, concomitant diseases, nicotine abuse, anticoagulation status, previous oncological therapy and surgery, etc. were acquired. Furthermore, surgery-related data (site and type of reconstruction, size and location of implant/tissue expander, intraoperative complications) and data on the postoperative course (early and late complications, revision surgeries, number of total surgeries required, etc.) were acquired.
The five-level modified Clavien-Dindo classification is used to objectively classify postoperative complications, to allow further comparisons between treatment options, different time periods and correlations to health-related quality of life. Postoperative changes in health-related quality of life are measured using the BREAST-Q questionnaire, an effective and reliable patient-reported outcome measure in breast reconstruction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous Breast Reconstruction | Patients undergoing autologous breast reconstruction with free flaps |
| |
| Alloplastic Breast Reconstruction | Patients undergoing alloplastic breast reconstruction with implants or expander prosthesis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BREAST-Q Questionnaire | Other | Patient-reported outcome measure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complications | The five-level modified Clavien-Dindo classification is used to objectively classify postoperative complications. A subgroup analysis will be done for complications requiring revision surgery under general anesthesia and complications not requiring revision surgery under general anesthesia. | Retrospective data analysis at the time of study inclusion (up to 10 years postoperative) |
| Measure | Description | Time Frame |
|---|---|---|
| Health-related quality of life and satisfaction | Postoperative changes in health-related quality of life are measured using the BREAST-Q questionnaire (postoperative, reconstructive module), an effective and reliable patient-reported outcome measure in breast reconstruction. Questions in each category can be answered on a scale from 0 to 100, with 100 indicating the highest satisfaction or well-being. |
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Inclusion Criteria:
Exclusion Criteria:
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Female breast cancer patients between 18 and 80 years who underwent autologous or alloplastic breast reconstruction at our department, willing to participate in this study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Graz | Graz | 8036 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41722472 | Derived | Luze H, Muller-Huck H, Stella C, Hasiba-Pappas S, Hubmer M, Justich I, Winter R, Peintinger F, Kamolz LP, Nischwitz SP. The complex relation of complications and long-term satisfaction in breast reconstruction after mastectomy: A comparative clinical study. J Plast Reconstr Aesthet Surg. 2026 Apr;115:24-32. doi: 10.1016/j.bjps.2026.02.001. Epub 2026 Feb 10. |
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Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis
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| ID | Term |
|---|---|
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| Retrospective data analysis at the time of study inclusion (up to 10 years postoperative) |