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Table 2 Flow Chart

From: Postsurgical pain outcome of vertical and transverse abdominal incision: Design of a randomized controlled equivalence trial [ISRCTN60734227]

Visit

1

(=Screening)

2

(OP)

3

(day1 post OP)

4

(day 2 post OP)

5

(day 5 post OP)

6

(day of discharge)

7

(day 30 post OP) by phone

8

(1 year +/- 1 month post OP)

Extra-visit

(secondary endpoint, AE or SAE)

Past medical history

X

        

Informed consent

X

        

Physical examination including personal data

X

      

X

X

Basic study-related examination (for each secondary endpoint, AE, SAE)

X (ranking by the patient)

X (ranking by the surgeon)

X

X (including survey and documentation of the amount of the analgesic drugs demanded, VAS and Pain-Sensation Scale)

X

X (incl. Second ranking by the patient)

X

X

X

Blinded changing of the wound dressing

  

X§

      

Ultrasound of the abdominal wall

       

X

X

Lung function test

X

      

X

 

Laboratory parameters

X

 

X

 

X

   

X

Medication

X

      

X

X

  1. § if necessary, Basic study-related Examination (= physical examination for each second endpoint or adverse event/severe adverse event), Physical examination (= including personal data, Height in cm, Weight in kg, vital signs); Laboratory Parameters (= serum chemistry, clotting, hematology).
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