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Table 1 Trial progression portrayed as per Standard Protocol Items: Recommendation for Interventional Trials (SPIRIT) guidelines

From: Robotic versus Open Pancreatoduodenectomy for Pancreatic and Periampullary Tumors (PORTAL): a study protocol for a multicenter phase III non-inferiority randomized controlled trial

Event

Preoperative setting (3 to 14 days pre-op)

Day of surgery

POD 1

POD 2

POD 3

POD 5

POD8/discharge day

POD 14

POD 30

POD 90

6 months post-op

1 year post-op

2 years post-op/time of death

Eligibility screening

X

            

Informed consent

X

            

Baseline characteristics

X

            

Arm allocation

X

            

QoL questionnaire (EQ-5D-5 L)

X

     

X

X

X

X

X

X

 

Intraoperative outcomes

 

X

           

Postoperative outcomes/secondary endpoints

  

X

X

X

X

X

X

X

X

   

Primary endpoint assessment

      

X

  

X

   

Recurrence-free and overall survival assessment

            

X

  1. pre-op preoperative, post-op postoperative, POD postoperative day, QoL quality of life
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Trials

ISSN: 1745-6215