Short-term results of a randomized controlled trial comparing primary suture with primary glued mesh augmentation to prevent incisional hernia.

ABSTRACT

BACKGROUND: Incisional hernia is one of the most frequent postoperative complications after abdominal surgery. Patients with an abdominal aortic aneurysm and patients with a body mass index of 27 or higher have an increased risk to develop incisional hernia. Primary mesh augmentation is a method in which the abdominal wall is strengthened to reduce incisional hernia incidence. This study focused on the short-term results of the PRImary Mesh Closure of Abdominal Midline Wounds trial, a multicenter double blind randomized controlled trial. METHODS: Between 2009 and 2012 patients were included if they were operated via midline laparotomy, and had an abdominal aortic aneurysm or a body mass index of 27 or higher. Patients were randomly assigned to either receive primary suture, onlay mesh augmentation (OMA), or sublay mesh augmentation. RESULTS: Outcomes represent results after 1-month follow-up. A total of 480 patients were randomized. During analysis, significantly (P = 0.002) more seromas were detected after OMA (n = 34, 18.1%) compared with primary suture (n = 5, 4.7%) and sublay mesh augmentation (n = 13, 7%). No differences were discovered in any of the other outcomes such as surgical site infection, hematoma, reintervention, or readmission. Multivariable analysis revealed an increase in seroma formation after OMA with an odds ratio of 4.3 (P = 0.004) compared with primary suture and an odds ratio of 2.9 (P = 0.003) compared with sublay mesh augmentation. CONCLUSIONS: On the basis of these short-term results, primary mesh augmentation can be considered a safe procedure with only an increase in seroma formation after OMA, but without an increased risk of surgical site infection.