Double‐blind randomized controlled trial of collagen mesh for the prevention of abdominal incisional hernia in patients having a vertical rectus abdominis myocutaneus flap during surgery for advanced pelvic malignancy

Aim The study investigated the effect of collagen mesh‐assisted closure at the donor site in preventing the formation of incisional hernia following construction of a vertical rectus abdominis myocutaneus (VRAM) flap as part of pelvic surgery for recurrent colorectal cancer. Method The study was a double‐blinded randomized controlled superiority trial that was designed and performed according to the Consolidated Standards of Reporting Trials (CONSORT) Statement. Eligible patients undergoing surgery that included a VRAM flap for advanced colorectal pelvic malignancy were prospectively randomized to conventional abdominal wound closure or collagen mesh‐assisted closure. The primary end‐point was incisional herniation at 1 year confirmed by CT. Secondary end‐points were CT‐verified incisional herniation at 3 and 36 months, clinically recognizable incisional herniation, donor‐site and reconstructive‐site complications, surgical mortality, postoperative morbidity, postoperative recovery and survival. Results In total, 58 (29 conventional closure; 29 mesh‐assisted closure) patients were included. At 1 year, incisional herniation on the CT scan was found in 12 (50%) of 24 patients in the conventional closure group, and in 8 (33%) of 24 in the mesh‐assisted closure group (P = 0.38). No significant difference between the groups was found in surgical mortality, early or late complications or survival. Donor‐site morbidity was comparable between the two groups. Conclusion No preventative effect of collagen mesh‐assisted closure was observed following VRAM flap reconstruction.