A double-blind randomised controlled trial of collagen mesh for the prevention of abdominal Incisional hernia in patients having a vertical rectus abdominis myocutaneus (VRAM) flap during surgery for advanced pelvic malignancy.

Aim: The study investigated the effect of collagen mesh-assisted closure at the donor site in preventating the formation of incisional hernia following a vertical rectus abdominis myocutaneus (VRAM) flap as part of pelvic surgery for recurrent colorectal cancer.. Method: The study was a double blinded randomised controlled superiority trial performed designed according to the Consort Statement. Eligible patients undergoing surgery for advanced colorectal pelvic malignancy including a VRAM flap were prospectively randomised to conventional abdominal wound closure or collagen mesh-assisted closure. The primary endpoint was incisional herniation at one year confirmed by computerised tomography (CT). Secondary endpoints were CT-verified incisional herniation at three and 36 months, clinically recognizable incisional herniation, donor site and reconstructive site complications, surgical mortality, postoperative morbidity, postoperative recovery and survival. Results: 58 (29 conventional closure; 29 mesh-assisted closure) patients were included. At one 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.