Persistent Pain After Reconstruction Following Mastectomy
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Cross-Sectional
|Official Title:||Persistent Pain After Reconstruction Following Mastectomy|
- The risk of developing persistent if reconstructed [ Time Frame: Cross-sectional, 2-3 years after surgery for breast cancer ] [ Designated as safety issue: No ]The risk of developing persistent if reconstructed compared to patients mastectomized without reconstruction expressed as an odds ratio.
- Prevalence of persistent pain after reconstruction after mastectomy [ Time Frame: Cross-sectional, 2-3 years after surgery for breast cancer ] [ Designated as safety issue: No ]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.
- Prevalence of sensory disturbances after reconstruction after mastectomy [ Time Frame: Cross-sectional, 2-3 years after surgery for breast cancer ] [ Designated as safety issue: No ]
|Study Start Date:||January 2008|
|Study Completion Date:||April 2008|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
Patients treated with mastectomy without reconstruction
Patients treated with mastectomy followed by reconstruction
Reconstructive surgery after mastectomy, either by expander or autologous tissue. Includes both primary and secondary 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01738048
|Copenhagen, Denmark, 2100|
|Principal Investigator:||Kenneth G Andersen, MD||Rigshospitalet, University of Copenhagen|