From: Chimney Trial: study protocol for a randomized controlled trial
Schedule of events | Baseline | Procedure | Discharge | 30 days ±3 days | 1 year ±14 days | 3 years ±30 days | 5 years ±30 days | Unscheduled visit |
---|---|---|---|---|---|---|---|---|
Informed consent | X | |||||||
Demographics and medical history | X | |||||||
QoL (RAND-36) | X | X | X | X | X | |||
QoL (colostomy impact score) | X | X | X | X | ||||
Procedure details | X | |||||||
CT scan findings | X | X | ||||||
Protocol deviation | Xa | Xa | Xa | Xa | Xa | Xa | Xa | Xa |
Complications | Xa | Xa | Xa | Xa | Xa | Xa | Xa | |
Study closure form | Xb |