Visit | 1 | 2 | 3 |
---|---|---|---|
Screening | Day of operation | Post-operative day 30 | |
Inclusion and exclusion criteria, and written informed consent | X | ||
Baseline demographic data | X | ||
Randomisation | X | ||
Primary endpoint | X | X | |
Tolerability of intervention | X | X | |
Duration of procedure | X | ||
Primary success rate | X | ||
Survival | X | ||
Complications | X | X | |
Serious adverse events | X | X |