Table 2

Flow Chart ISSAAC Trial


Visit 1
(Screening)
Visit 2
(day 0)
Visit 3
(day 2 ± 1)
 Visit 4
(day of discharge
or the day before)
Visit 5
(day 30 ± 5)
 Visit 6
(12 ± 1 months
post surgery)
Informed consent
 X




Demographic data*
 X




BMI
 X




Smoker/non-smoker
 X




Inclusion/exclusion
 X




Medical history
 X




Physical examination
 X
X1)
 X1)
 X1)
 X2)
Reason for surgery
 X




Surgery
X



Board certified surgeon
X



Deviations from surgical procedure as described in protocol
X



Ultrasound of the abdominal wall




X
Abdominal Adverse Event/Serious Adverse Event
X
 X
 X
 X
 X
Re-operation due to burst abdomen necessary?

X
 X
 X
 X
Wound infection

X
 X
 X
discharge


X

1) of the abdomen and the laparotomy wound

2) of the abdomen

* date of birth, gender, weight, height

Fischer et al. BMC Surgery 2008 8:12   doi:10.1186/1471-2482-8-12