Study visits
| Visit | 1 | 2 | 3 | 4 | 5 | 6 | 7 |
| Enrolment and randomisation | Operation | ||||||
| Day related to index operation | Day 0 | POD 3 | POD 7 | POD 14/day of discharge | POD 30 | 3 months post-OP | |
| Type of visit | Outpatient | Inpatient | Inpatient | Inpatient | Inpatient | Outpatient | Phone* |
| Visit window | ±0 | ±0 | ±0 | ±0 | ±2 | ±2 | ±2 |
| Inclusion/exclusion criteria | X | ||||||
| Baseline/demographic data | X | ||||||
| Prior/concomitant diseases | X | ||||||
| Prior/concomitant medication | X | X | X | X | X | X | X |
| Trial intervention | X | ||||||
| Operative procedure | X | ||||||
| Laboratory parameters† | X | X | X | ||||
| Pregnancy test‡ | X | ||||||
| Drainage amylase | X | (X) | (X) | (X) | (X) | ||
| Primary endpoint | X | ||||||
| Secondary endpoints | |||||||
| AE/SAE | X | X | X | X | X | X | X |
*In-hospital visit in case of ongoing hospital stay or readmission to hospital.
†Standard peri-interventional/perioperative procedures. Documentation of serum values of amylase and/or lipase, bilirubin, haemoglobin, erythrocytes, leucocytes, thrombocytes, International Normalised Ratio, creatinine clearance/glomerular filtration rate, C-reactive protein.
‡Females with childbearing potential only.
AE, adverse event; OP, operation; POD, postoperative day; SAE, serious AE.