Prevention of Incisional Hernia after Kidney Transplantation: Study Protocol for a Randomized Controlled Trial

Abstract

Abstract Background: Incisional hernia is a common complication after kidney transplantation with an incidence of 1.6-18%. Concerning non-transplant patients, a recently published meta-analysis describes a reduction of the incidence of incisional hernia of up to 85% due to prophylactic mesh replacement in elective, midline laparotomy. The aim of our study is to show a reduction of the incidence of incisional hernia after kidney transplantation with minimal risk for complication. Methods/design: This is a blinded, randomized controlled trial comparing time to incisional hernia over a period of 24 months between patients undergoing kidney transplantation and standardized abdominal closure with or without prophylactic placement of ProGrip™ (Medtronic. Fridley, Minnesota. USA) mesh in an onlay position. As we believe that the mesh intervention is superior to the standard procedure in reducing the incidence of hernia, this is a superiority trial. Discussion: The high risk for developing incisional hernia following kidney transplantation might be reduced by prophylactic mesh placement. ProGrip™ mesh features polylactic acid (PLA) microgrips that provides immediate, strong and uniform fixation. The use of this mesh combines the effectiveness demonstrated by the macropore propylene meshes in the treatment of incisional hernias, a high simplicity of use provided by its capacity for self-fixation that doesn´t increase significantly surgery time, and safety. Trial registration: ClinicalTrials.gov. ID: NCT04794582. Registered on 08 March 2021. Protocol version 2.0. (02-18-2021)