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Table 2 Assessment and visit schedule (SPIRIT figure)

From: A study protocol for a feasibility randomised controlled trial investigating videoendoscopic radical inguinal lymphadenectomy versus open radical inguinal lymphadenectomy in patients with penile cancer (VELRAD)

Time point

Pre-intervention

Intervention phase

Follow up phase

Assessments

Screening

Baseline

 

1 week

3–4 weeks

3 months

6 months

Inclusion and exclusion criteria

X

      

Consent

X

      

Registration

 

X

     

Randomisation

X

      

Demographic data

 

X

     

Medical history

 

X

     

Concomitant medications

 

X

     

Tumour characteristics (including stage)

 

X

     

CT scan

     

X

X

Outcome data

   

X

X

X

X

AE reporting

  

X

X

X

X

X