Prophylactic Intraperitoneal Onlay Mesh Reinforcement Reduces the Risk of Incisional Hernia, Two-Year Results of a Randomized Clinical Trial.

BACKGROUND: Incisional hernias still are a major concern after laparotomy and are causing substantial morbidity. This study examines the feasibility, safety and incisional hernia rate of the use of a prophylactic intraperitoneal onlay mesh stripe (IPOM) to prevent incisional hernia following midline laparotomy.

METHODS: This prospective, randomized controlled trial randomly allocated patients undergoing median laparotomy either to mass closure of the abdominal wall with a PDS-loop running suture reinforced by an intraperitoneal composite mesh stripe (Group A) or to the same procedure without the additional mesh stripe (Group B). Primary endpoint was the incidence of incisional hernias at 2 years following midline laparotomy. Secondary endpoints are were the feasibility, the safety of the mesh stripe implantation including postoperative pain, and the incidence of incisional hernias at 5 years.

RESULTS: A total of 267 patients were included in this study. Follow-up data 2 years after surgery was available from 210 patients (Group A = 107; Group B = 103). An incisional hernia was diagnosed in 18/107 (17%) patients in Group A and in 40/103 (39%) patients in Group B (p < 0.001). A surgical operation due to an incisional hernia was conducted for 12/107 (11%) patients in Group A and for 24/103 (23%) patients in Group B (p = 0.039). In both groups, minor and major complications as well as postoperative pain are reported with no statistically significant difference between the groups, even in contaminated situations.

CONCLUSIONS: This first randomized clinical trial indicates that the placement of a non-absorbable IPOM-stripe with prophylactic intention may significantly reduce the risk for a midline incisional hernia.

TRIAL REGISTRATION: Ref. NCT01003067 (clinicaltrials.gov).