Use of a bioabsorbable mesh in midline laparotomy closure to prevent incisional hernia: randomized controlled trial.

Abstract

The objective was to assess the effectiveness and safety of a bioabsorbable mesh at the time of closure of a midline laparotomy for IH prevention. A multicenter, randomized clinical trial including patients undergoing abdominal surgical procedures through a midline laparotomy incision was designed. In the group of mesh (n=167) the incision was closed using a continuous polydioxanone suture (PDS) plus a bioabsorbable mesh. In the control group (n=165) a continuous PDS single layer suture was only used. Patients were randomly assigned (1:1) to the two groups. The primary outcome was the incidence of IH at 6, 12 and 24 months. Assessment of IH was done using a CT scan. At 6 months, the rates of IH were 15.2% and 24.8% in the experimental and control groups, respectively (relative risk [RR] 0.66, 95% confidence interval [CI] 0.38-0.98, P = 0.042). At 12 months, the rate of IH continued to be significantly lower in the experimental group (21.4% vs. 33.1%, P = 0.033), but at 24 months, there were no significant differences between the study groups with a follow-up rate of only 37.5%. The number needed to treat (NNT) was 11 and 9 at 6 and 12 months, respectively. The bioabsorbable mesh significantly prevented IH during the first year. Not reliable conclusions can be drawn across the second year. This may suggest that the any of the closing technique assessed in this study would have a "palliative" transient effect for preventing IH in the long-term.