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Table 2 Trial visits

From: Evaluation of robotic versus open partial pancreatoduodenectomy—study protocol for a randomised controlled pilot trial (EUROPA, DRKS00020407)

Visit

1

2

3

4

5

6

7

8

1–14 days before surgery

Day of surgery (day 0)

POD 4

POD 8

POD 12

Day of hospital discharge

POD 30

POD 90

Outpatient/inpatient

Inpatient

Inpatient/telephone

Eligibility criteria

X

       

Informed consent

X

       

Baseline demographics and clinical data

X

       

Randomisation

X

       

Quality of life questionnaire (SF-36)

X

     

X

X

Quality of recovery (QoR-15)

X

 

X

     

Intervention

 

X

      

Serious intraoperative complications

 

X

      

Intraoperative secondary endpoints (e.g. operation time, blood loss, conversion rate, resection status)

 

X

      

Surgeon’s mental workload/stress

 

X

      

Assessment of primary endpoint (CCI)

  

X

X

X

X

X

X

Postoperative secondary endpoints (e.g. re-interventions, pain, time to functional recovery)

  

X*

X

X

X

X

X

Procedure-related costs, all inpatient hospital costs

       

X

  1. POD postoperative day
  2. *Pain needs to be assessed on POD 2 and 4