Table 2.

Incidence of incisional hernia in all patients included in intention-to-treat analysis

	Rate of primary event (%)	Hazard ratio (95% CI)	p value
Adjusted cox-regression
Onlay mesh (group II) vs no onlay mesh (group I and III)	2/32 (6.25) vs 14/67 (20.90)	2.519 (0.455; 13.939)	0.290
MonoPlus (group I and group II) vs Monomax (group III)	6/66 (9.09) vs 10/33 (30.30)	2.666 (0.797; 8.912)	0.111
Male vs female	15/94 (15.96) vs 1/10 (10.00)	0.498 (0.063; 3.961)	0.510
Age		1.171 (0.558; 2.457)	0.677
Sensitivity analysis
MonoPlus (group I) vs Monoplus and onlay mesh (group II)	4/34 (11.76) vs 2/32 (6.25)	2.422 (0.442; 13.281)	0.308
MonoMax (group III) vs Monoplus and onlay mesh (group II)	10/33 (30.30) vs 2/32 (6.25)	6.364 (1.379; 29.376)	0.018
Male vs female	15/94 (15.96) vs 1/10 (10.00)	0.342 (0.032; 3.607)	0.372
Age (unit = 10 years)		0.841 (0.407; 2.405)	0.737
Daily number of cigarettes (unit = 1 cigarette)		0.965 (0.059; 1.587)	0.249
Cardiovascular disease (no vs yes)	5/37 (13.51) vs 11/65 (16.92)	0.923 (0.250; 3.402)	0.904
Malignancy (no vs yes)	15/93 (16.13) vs 0/7 (0.00)	Incalculable	0.995
Previous surgery (no vs yes)	4/20 (20.00) vs 12/84 (14.29)	1.992 (0.463; 8.576)	0.355

Calculated using a Cox regression model with age and gender as covariates. Also sensitivity analyses with a Cox regression model adjusted for baseline characteristics (covariates) unequally distributed between the groups (indicator was a p-value from ≤ 0.2)

ITT intention to treat, CI confidence interval