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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