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

Daniela Kniepeiss†,
James Elvis Waha†,
Thomas Auer,
Andrea Berghold and
Peter SchemmerEmail author

†Contributed equally

Trials201920:371

https://doi.org/10.1186/s13063-019-3477-2

Received: 3 December 2018
Accepted: 29 May 2019
Published: 20 June 2019

Open Peer Review reports

Abstract

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.