Interrupted or continuous slowly absorbable sutures – Design of a multi-centre randomised trial to evaluate abdominal closure techniques INSECT-Trial [ISRCTN24023541]

Table 3 Flow Chart INSECT-Trial

Visit	1 (=Screening)	2 (OP)	3 (day 2 post OP)	4 (day of discharge)	5 (6 months +/- 1 month post OP)	6 (12 months +/- 1 month post OP)	7 (three years after operation)	Extra-visit (secondary endpoint, AE or SAE)
Past medical history	X
Informed consent	X
Physical examination including the personal data	X				X	X
Basic study-related examination I (for each secondary endpoint, AE, SAE)	X (ranking of the patient before operation)	X (ranking of the surgeon)	X	X (ranking of the patient after operation)	X	X (ranking of the patient after operation)		X
Basic study-related examination II							X
Ultrasound of the abdominal wall					X	X		X
Lung function test	X		X
Medication	X				X	X		X

Past medical history: past medical history, past surgical history, indication for operation, diabetes, renal insufficiency, smoking, lung disease
Personal data: gender, date of birth, height in cm, weight in kg
Basic study related examination I: physical examination for evaluation of all secondary endpoints including adverse events/serious adverse events where appropriate
Basic study related examination II: telephone visit of patient and/or practitioner and physical re-examination if necessary in case of unclear abdominal wall status
Physical examination: vital signs (blood pressure systolic/diastolic in mmHg, heartrate in /min), prior abdominal incisions, rectus diastasis
Ultrasound: standard abdominal wall investigation (if hernia present: length and width in cm)
Lung function test: FEV, vital capacity %

ISSN: 1471-2482