No Reduction in Parastomal Hernia Rate 3 Years After Stoma Construction With Prophylactic Mesh: Three-year Follow-up Results From STOMAMESH—A Multicenter Double-blind Randomized Controlled Trial

The primary objective was to compare rates of parastomal hernia (PSH) 3 years after stoma construction with prophylactic mesh or no mesh. A secondary objective was to compare complications requiring reintervention within 3 years. BACKGROUND: Recent studies have shown that a prophylactic mesh does not reduce the rate of PSH contrary to older studies. Long-term data on efficacy and safety is however scarce. METHODS: A randomized controlled double-blind multicenter trial. Patients planned for permanent end colostomy were randomized to either prophylactic mesh in the retromuscular position around the stoma site or no mesh. They were evaluated for PSH clinically and with computed tomography (CT) 3 years after stoma construction. Medical records of all patients included were also reviewed at 3 years to detect any abdominal or abdominal wall surgery during that period. RESULTS: A total of 232 patients were randomized. At 3 years, 154 patients were available for clinical evaluation and 137 underwent a CT scan. No significant difference in PSH rates was seen between the treatment allocation arms (clinical: P=0.829 and CT: P=0.761, respectively), nor was there a significant difference in the number of reinterventions, but 2 patients had their mesh removed at emergency surgery. CONCLUSIONS: Prophylactic mesh does not reduce the rate of PSH and cannot be recommended for routine use.