Table 1
Schematic timeline of the PIDuSA trial
| Timeline of the PIDuSA trial | Screening | Surgery (day 0) | Visit 1 (day 1, a.m.) | Visit 2 (day 1, p.m.) | Visit 3 (day 2 a.m.) | Visit 4 (day 2 p.m.) | Visit et seq. (day a.m.) | Visit et seq. (day p.m.) | Final examination after SmartPill® excretion |
|---|---|---|---|---|---|---|---|---|---|
| Informed consent | X | ||||||||
| Inclusion/exclusion criteria | X | X | |||||||
| Medical history, demographics, laboratory test | X | ||||||||
| Audible bowel sounds, abdominal distension | X | X | X | X | X | X | X | X | |
| Concomitant medication | X | X | X | X | X | X | X | X | X |
| Application of SmartPill® | X | ||||||||
| SmartPill® excretion? | X | X | X | X | X | X | |||
| AEs/SAEs | X | X | X | X | X | X | X | X | |
| Nausea/vomiting, flatus and defecation? | X | X | X | X | X | X | |||
| Documentation of physiotherapy and prokinetics/laxatives |  | ||||||||
| Documentation of defecation and solid food tolerance (patient) |  | ||||||||
AEs, adverse events; SAEs, serious adverse events.