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Table 1 Participant timeline

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

 
  1. Legend: CT computed tomography, QoL quality of life
  2. aComplete if applicable
  3. bComplete when lost to follow-up, consent withdrawal or subject has completed all study-related visits