gms | German Medical Science

Background: It is assumed that incisional hernias occur in up to 20% of all open abdominal surgeries. This study examines the use of a prophylactic intraperitoneal onlay mesh (IPOM) to prevent incisional hernia following midline laparotomy.

Materials and methods: This prospective, randomized controlled trial was started in August 2008. Patients undergoing median laparotomy were randomly allocated either to abdominal wall closure according to Everett with a PDS-loop running suture and with additional IPOM (group A) or the same procedure without the additional IPOM (group B). Primary endpoints were the incidence of incisional hernias at 2 and 5 years following midline laparotomy. Secondary endpoints are the feasibility and safety of the mesh implantation even in contaminated situations (Altemeier grade I – III), and the identification of risk factors for incisional hernias. Patients with contaminated situation grade IV were excluded from this study. This study is registered on www.clinicaltrial.gov.

Results: Until May 2013 a total of 266 patients were included in this study, 131 patients in group A and 135 patients in group B. Six out of the 266 original procedures were emergency operations (group A=2; group B=4). Separated to the different grade of wound contamination the allocation in group A is n=39 grade I; n=31 grade II, n=61 grade III, and in group B: n=40 grad I; n=31 grad II; n=64 grad III, respectively (p=0.94). There were no differences regarding patient characteristics (age, BMI, gender, smoker, diabetes) between group A and B. So far 17/131 in group A and 18/134 in group B died or had a re-laparotomy. Follow-up data 2 years after surgery were available from 204 patients (group A=105; group B=99). An incisional hernia was diagnosed in 18/105 (17%) patients in group A and in 40/99 (40%) patients in group B (p<0.01). A surgical operation due to an incisional hernia was conducted for 12 patients in group A and for 22 subjects in group B (p=0.039). In 3/129 patients the mesh had to be removed. No mesh penetration and no bowel obstruction with the need for surgical re-intervention did occur. One burst abdomen occurred in group A and one in group B. The IPOM from three patients allocated to group A required surgical removal because of a mesh-infection.

Conclusion: The results after two years indicate that the placement of an IPOM with prophylactic intention significantly reduces the risk for an incisional hernia. Furthermore, the procedure is feasible and seems to be safe. Additionally, our results imply that the number of incisional hernia following midline laparotomy is currently underestimated.