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, MN, 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 provide 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 does not increase significantly surgery time, and safety.

Trial registration

ClinicalTrials.gov NCT04794582. Registered on 08 March 2021. Protocol version 2.0. (02–18-2021).

Details

Title
Prevention of incisional hernia after kidney transplantation: study protocol for a randomized controlled trial
Author
Gómez-Dos-Santos, Victoria 1 ; López-Plaza, José Antonio 2   VIAFID ORCID Logo  ; Molina-Villar, José Manuel 3 ; Blázquez-Hernando, Luis 3 ; Diez-Nicolás, Víctor 1 ; Jiménez-Cidre, Miguel 1 ; Porrero-Guerrero, Belén 3 ; Rodríguez-Patrón, Rafael 1 ; Arias-Fúnez, Fernando 1 ; Muriel-García, Alfonso 4 ; Fernández-Cebrián, José María 3 ; Burgos-Revilla, Francisco Javier 1 

1  Ramón Y Cajal Hospital, Surgical Research in Urology and Renal Transplantation, IRYCIS, Alcalá University, Urology Department, Kidney Transplant Surgery, Alcalá de Henares, Spain (GRID:grid.7159.a) (ISNI:0000 0004 1937 0239) 
2  Ramón Y Cajal Hospital, Urology Department, Alcalá de Henares, Spain (GRID:grid.411347.4) (ISNI:0000 0000 9248 5770) 
3  Ramón Y Cajal Hospital, Alcalá University, General and Visceral Surgery Department, Alcalá de Henares, Spain (GRID:grid.7159.a) (ISNI:0000 0004 1937 0239) 
4  Ramón Y Cajal Hospital, IRYCIS, CIBERESP, Alcalá University, Biostatistics Department, Alcalá de Henares, Spain (GRID:grid.7159.a) (ISNI:0000 0004 1937 0239) 
Pages
528
Publication year
2023
Publication date
Dec 2023
Publisher
Springer Nature B.V.
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1186/s13063-023-07545-0
ProQuest document ID
2850407607
Copyright
© The Author(s) 2023. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.