Prevention of incisional hernia after kidney transplantation: study protocol for a randomized controlled trial
Victoria Gómez-Dos-Santos,
José Antonio López-Plaza,
José Manuel Molina-Villar,
Luis Blázquez-Hernando,
Víctor Diez-Nicolás,
Miguel Jiménez-Cidre,
Belén Porrero-Guerrero,
Rafael Rodríguez-Patrón,
Fernando Arias-Fúnez,
Alfonso Muriel-García,
José María Fernández-Cebrián,
Francisco Javier Burgos-Revilla
Affiliations
Victoria Gómez-Dos-Santos
Urology Department, Kidney Transplant Surgery, Ramón Y Cajal Hospital, Surgical Research in Urology and Renal Transplantation, IRYCIS, Alcalá University
José Antonio López-Plaza
Urology Department, Ramón Y Cajal Hospital
José Manuel Molina-Villar
General and Visceral Surgery Department, Ramón Y Cajal Hospital, Alcalá University
Luis Blázquez-Hernando
General and Visceral Surgery Department, Ramón Y Cajal Hospital, Alcalá University
Víctor Diez-Nicolás
Urology Department, Kidney Transplant Surgery, Ramón Y Cajal Hospital, Surgical Research in Urology and Renal Transplantation, IRYCIS, Alcalá University
Miguel Jiménez-Cidre
Urology Department, Kidney Transplant Surgery, Ramón Y Cajal Hospital, Surgical Research in Urology and Renal Transplantation, IRYCIS, Alcalá University
Belén Porrero-Guerrero
General and Visceral Surgery Department, Ramón Y Cajal Hospital, Alcalá University
Rafael Rodríguez-Patrón
Urology Department, Kidney Transplant Surgery, Ramón Y Cajal Hospital, Surgical Research in Urology and Renal Transplantation, IRYCIS, Alcalá University
Fernando Arias-Fúnez
Urology Department, Kidney Transplant Surgery, Ramón Y Cajal Hospital, Surgical Research in Urology and Renal Transplantation, IRYCIS, Alcalá University
Alfonso Muriel-García
Biostatistics Department, Ramón Y Cajal Hospital, IRYCIS, CIBERESP, Alcalá University
José María Fernández-Cebrián
General and Visceral Surgery Department, Ramón Y Cajal Hospital, Alcalá University
Francisco Javier Burgos-Revilla
Urology Department, Kidney Transplant Surgery, Ramón Y Cajal Hospital, Surgical Research in Urology and Renal Transplantation, IRYCIS, Alcalá University
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).
