PRevention of INCisional hernia after liver transplantation (PRINC trial): study protocol for a randomized controlled trial

BACKGROUND: Incisional hernia is a common complication after liver transplantation with an incidence of 5 to 46%. 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 liver transplantation with minimal risk for complication. METHODS/DESIGN: This is an unblinded, randomized controlled trial comparing time to incisional hernia over a period of 12 months between patients undergoing liver transplantation and standardized abdominal closure with or without prophylactic placement of Phasix™ (Bard – Davol Inc., Warwick, RI, 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 liver transplantation might be reduced by prophylactic mesh placement. Immunosuppressed patients are at high risk for developing surgical-site infections. We chose a mesh which has anti-inflammatory properties and is fully resorbed after 18 months. TRIAL REGISTRATION: ClinicalTrials.gov, ID: 03222102. Registered retrospectively on 17 July 2018. Protocol version 1.4, 7 October 2018. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-019-3477-2) contains supplementary material, which is available to authorized users.