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| Name | Class |
|---|---|
| Danish Breast Cancer Cooperative Group | OTHER |
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A cross sectional study to determine the prevalence of persistent pain after reconstructive surgery after mastectomy for breast cancer, with a comparative analysis of a cohort treated with mastectomy without reconstruction.
The aim of the study is to determine if reconstruction of the breast after mastectomy increases the risk of reporting persistent pain 2-3 years after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mastectomy | Patients treated with mastectomy without reconstruction | ||
| Reconstruction | Patients treated with mastectomy followed by reconstruction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reconstruction | Procedure | Reconstructive surgery after mastectomy, either by expander or autologous tissue. Includes both primary and secondary reconstruction |
|
| Measure | Description | Time Frame |
|---|---|---|
| The risk of developing persistent if reconstructed | The risk of developing persistent if reconstructed compared to patients mastectomized without reconstruction expressed as an odds ratio. | Cross-sectional, 2-3 years after surgery for breast cancer |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of persistent pain after reconstruction after mastectomy | Self reported pain expressed as a percentage of the population of patients reconstructed with expander and autologous tissue. Pain intensity measured with a numerical rating scale 0-10, divided in mild (NRS 1-3), moderate (4-6) and severe pain (7-10). Patients regarded as having clinically relevant pain: NRS 4 or above, at least at a weekly basis. |
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Inclusion Criteria:
Exclusion Criteria:
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Nationwide cross-sectional cohort
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth G Andersen, MD | Rigshospitalet, University of Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Copenhagen | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21435953 | Background | Andersen KG, Kehlet H. Persistent pain after breast cancer treatment: a critical review of risk factors and strategies for prevention. J Pain. 2011 Jul;12(7):725-46. doi: 10.1016/j.jpain.2010.12.005. Epub 2011 Mar 24. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D059350 | Chronic Pain |
| D010146 | Pain |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D019651 | Plastic Surgery Procedures |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| Cross-sectional, 2-3 years after surgery for breast cancer |
| Prevalence of sensory disturbances after reconstruction after mastectomy | Cross-sectional, 2-3 years after surgery for breast cancer |
| D017437 |
| Skin and Connective Tissue Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |