The study at hand aimed to analyze the replicability of the observed treatment effects in these studies published by Koeppe et al. and Stolberg-Stolberg et al.
see Protocol
Study Type
OBSERVATIONAL
Enrollment
32,953
30-day mortality
Death from any cause during the first 30-days after surgery.
Time frame: 30 days
Overall survival (OS)
Time from discharge of index hospitalization to death of any case.
Time frame: up to 12 years
Major adverse events during index case
See above, only events during hospitalization
Time frame: through hospital stay, an average of 16 days
Major adverse events after discharge
Time from discharge of index hospitalization to MAE as defined above
Time frame: up to 12 years
Thromboembolic events during index
See above, only events during hospitalization
Time frame: through hospital stay, an average of 16 days
Thromboembolic events (or death) after discharge
Time from discharge of index hospitalization to a thromboembolic event or death of any case.
Time frame: up to 12 years
Surgical complications during index case
See above, only events during hospitalization
Time frame: through hospital stay, an average of 16 days
Surgical complications after discharge
Time from discharge of index hospitalization to surgical complications, with death being considered as a competing risk event.
Time frame: up to 12 years
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Implant-associated complication during index
See above, only events during hospitalization
Time frame: through hospital stay, an average of 16 days
Non-Implant-associated complication during index
See above, only events during hospitalization
Time frame: through hospital stay, an average of 16 days
Minor outpatient complications after discharge
Time from discharge of index hospitalization to minor outpatient complications, with death being considered as a competing risk event.
Time frame: up to 12 years