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Table 1 Schedule of enrolment, interventions, and assessments

From: Clip placement to prevent delayed bleeding after colonic endoscopic mucosal resection (CLIPPER): study protocol for a randomized controlled trial

 

Study period

 

Enrolment

Allocation

Post-allocation

Close-out

Timepoint

Week − 1

EMR + 0

EMR+ 0

+ 1 month

+ 3 months

+ 6 months

+ 6 months

Enrolment:

       

 Eligibility screen

X

      

 Informed consent

X

      

 Allocation

 

X

     

Interventions:

       

 PC post EMR

  

X

    

 Questionnaires (EQ-5D, iMCQ, iPCQ)

  

X

X

X

X

 

 Control group without PC

  

X

    

Assessments:

       

 Collect baseline and procedure variables

X

X

X

    

 Collect primary outcome variables

  

X

X

   

 Standard of care surveillance colonoscopy

     

X

 

 Collect secondary outcome variables

     

X

X