Table 1 Schedule of study assessments
Study periods | Screening | Intervention | Follow-up | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
Visit | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 |
Time (day, month, year) | − 3 months | 0–5 days | 3 months | 6 months | 9 months | 1 year | 1.5 years | 2 years | 3 years | 4 years | 5 years |
Patient information and informed consent | x | ||||||||||
Demographics | x | ||||||||||
Medical history | x | ||||||||||
Inclusion/exclusion criteria | x | x | |||||||||
Physical examination | x | x | x | x | x | x | x | x | x | x | x |
Vital signs | x | x | x | x | x | x | x | x | x | x | x |
Laboratory tests | x | x | x | x | x | x | x | x | x | x | x |
Randomization | x | ||||||||||
Operation | x | ||||||||||
Complications | x | x | x | x | x | x | x | x | x | x | |
Primary variables | x | x | x | x | x | x | x | x | x | x | x |
Secondary variables | x | x | x | x | x | x | x | x | x | x | x |
Questionnaires | x | x | x | x | x | x | x | ||||
Adverse events | x | x | x | x | x | x | x | x | x | x | |