Visit | 1 | 2 | 3 | 4 | 5 | 6 |
---|---|---|---|---|---|---|
Screening visit | Day of index OP | Daily postoperative ward visits | Day of discharge | Day 40 post OP (by phone) | 3 months post-OP (optional) | |
Past and current medical history | X | |||||
Informed consent | X | |||||
Physical examination and personal data (e.g., height, weight, age) | X | |||||
Intraoperative randomisation (additional coverage yes/no) | X | |||||
Basic study-related examination (to access endpoints) | X | X | X | X | X | |
Quality of life (EQ-5D questionnaire) | X | X | X | |||
AE, SAE | X | X | X | X | X | |
Drainage parameters (enzyme levels) | X | X | ||||
Survival | X | X | X | X | X |