A randomised, multi-centre, prospective, double blind pilot-study to evaluate safety and efficacy of the non-absorbable Optilene® Mesh Elastic versus the partly absorbable Ultrapro® Mesh for incisional hernia repair

Table 2 Tabular overview of the visits

	Visit 1 Pre- Surgery¹	Visit 2 Surgery 0 Day	Visit 3 Release	Visit 4 Clinic 21 Days	Visit 5 Telephone 4 Months	Visit 6 Clinic 6 Months²
Patient information	X
Informed Consent	X
Demographics incl. employment status and home activities	X
Body weight	X					X
Inclusion/Exclusion	X
Medical history incl. history hernia	X
Determination of potential risk factors	X
Clinical examination	X					X
Concomitant medication	X	X³	X	X	X	X
General health status	X			X		X
SF-36	X			X		X
Daily activity questionnaire	X			X		X
Intra-operative details		X
Adverse Events		X	X	X	X	X
Wound assessment			X	X		X
Seroma formation (sonography if indicated)			X	X		X
Pain score	X		X	X		X
Study termination						X

1) to be performed within 6 weeks before visit 2
2) or prematurely
3) concomitant medication except medication routinely given during a surgery and anaesthetic drug

ISSN: 1471-2482