From: Preloop trial: study protocol for a randomized controlled trial
Schedule of events | Baseline | Procedure | Discharge | 30 days ± 3 days | 10 months ± 14 days | 3 year ± 30 days | 5 years± 30 days | Unscheduled visit |
---|---|---|---|---|---|---|---|---|
Informed consent | X | |||||||
Demographics and medical history | X | |||||||
QoL | X | X | X | X | X | |||
Procedure details | X | |||||||
CT scan findings | X | |||||||
Protocol deviation | X* | X* | X* | X* | X* | X* | X* | X* |
Complications | X* | X* | X* | X* | X* | X* | X* | |
Study exit form | X** |