ABSTRACT
Background: Incisional hernia (IH) after abdominal surgery is a frequent surgical complication. Risk factors associated with IH are midline incisions, patients with an abdominal aneurysm of the aorta, and high BMI. Preventive measures include the use of the small-bites suture technique and/or placing a prophylactic mesh for reinforcement of the midline closure. Although recommended for high-risk patients, many surgeons are still reluctant to place a prophylactic mesh due to related complications. To counter these concerns, new synthetic resorbable meshes are being developed, such as the Deternia Self-Gripping Resorbable Mesh ("investigational device"). However, the effectiveness of this mesh in IH prevention has not been proved. Methods: The Mesh Augmented Reinforcement of Abdominal Wall Suture Line (MARS) study is a European, multicentre, prospective, single-arm study. A total of 120 patients scheduled for elective midline laparotomy, and for that reason at risk of developing IH, will be recruited in ~12 sites after informed consent. The sample size was estimated based on greater than 80% power, two-sided alpha of 0.05, an expected 12 month IH rate of 8% and a predefined performance goal of 18% (10% clinical margin). Midline incisions will be closed by the small bites closure technique with a minimum 4:1 suture-to-wound length ratio and reinforced by mesh placement in the retrorectus position. The primary outcome will be IH occurrence at 12-month postoperatively, evaluated both clinically and by ultrasound. Secondary outcomes will include mesh-related and postoperative complications, surgical characteristics, IH incidence at 2 and 3 years after surgery, and quality of life. Discussion: Currently, no conclusive evidence is available for synthetic resorbable meshes in a prophylactic setting to prevent IH. The MARS study will be the first prospective cohort study to investigate resorbable synthetic meshes and small bites closure to reduce IH incidence.
ABSTRACT
Background: Incisional hernia occurs approximately in 40% of high-risk patients after midline laparotomy. Prophylactic mesh placement has shown promising results, but long-term outcomes are needed. The present study aimed to assess the long-term incisional hernia rates of the previously conducted PRIMA trial with radiological follow-up. Methods: In the PRIMA trial, patients with increased risk of incisional hernia formation (AAA or BMI ≥27 kg/m2) were randomised in a 1:2:2 ratio to primary suture, onlay mesh or sublay mesh closure in three different countries in eleven institutions. Incisional hernia during follow-up was diagnosed by any of: CT, ultrasound and physical examination, or during surgery. Assessors and patients were blinded until 2-year follow-up. Time-to-event analysis according to intention-to-treat principle was performed with the Kaplan-Meier method and Cox proportional hazard models. Trial registration: NCT00761475 (ClinicalTrials.gov). Findings: Between 2009 and 2012, 480 patients were randomized: 107 primary suture, 188 onlay mesh and 185 sublay mesh. Five-year incisional hernia rates were 53.4% (95% CI: 40.4-64.8), 24.7% (95% CI: 12.7-38.8), 29.8% (95% CI: 17.9-42.6), respectively. Compared to primary suture, onlay mesh (HR: 0.390, 95% CI: 0.248-0.614, p < 0.001) and sublay mesh (HR: 0.485, 95% CI: 0.309-0.761, p = 0.002) were associated with a significantly lower risk of incisional hernia development. Interpretation: Prophylactic mesh placement remained effective in reducing incisional hernia occurrence after midline laparotomy in high-risk patients during long-term follow-up. Hernia rates in the primary suture group were higher than previously anticipated. Funding: B. Braun.
