Multicentre, prospective, randomized control non-inferiority trial of bladder catheter management in colon surgery
Serra-Aracil, Xavier (Parc Taulí Hospital Universitari. Institut d'Investigació i Innovació Parc Taulí (I3PT))
Hidalgo Rosas, Jose Manuel (Parc Taulí Hospital Universitari. Institut d'Investigació i Innovació Parc Taulí (I3PT))
Dominguez-Garcia, Arturo (Parc Taulí Hospital Universitari. Institut d'Investigació i Innovació Parc Taulí (I3PT))
Vallverdu, Helena (Hospital Universitari de Vic)
Millan, M. (Hospital Universitari i Politècnic La Fe (València))
Caro, Aleidis (Hospital Universitari Joan XXIII de Tarragona)
Delgado, Salvadora (Hospital Universitari MútuaTerrassa (Terrassa, Catalunya))
Gomez, C. (ALTHAIA. Xarxa Assistencial Universitària de Manresa)
Llorach-Perucho, Núria (Parc Taulí Hospital Universitari. Institut d'Investigació i Innovació Parc Taulí (I3PT))
Mora Lopez, Laura (Parc Taulí Hospital Universitari. Institut d'Investigació i Innovació Parc Taulí (I3PT))
CR-Vesical Cath-Study group

Fecha:	2023
Resumen:	Aim: Perioperative bladder catheterization is a controversial issue. Most current recommendations are based on data from open surgery extrapolated to enhanced recovery after surgery or fast-track programmes ranging between 24 and 48 h. The aim of this study is to provide a rationale for reducing catheterization time while at the same time avoiding acute urine retention (AUR), in patients undergoing scheduled laparoscopic colon surgery. Method: This is a multicentre, prospective, controlled, randomized non-inferiority study of bladder catheter management in patients undergoing scheduled laparoscopic colon surgery, randomized into two groups: experimental (with catheter removal immediately after surgery) and control (with catheter removal 24 h post-surgery). The main outcome will be the development of AUR, and secondary outcomes the development of urinary infection within the first 30 days and hospital stay. Demographic, surgical and pathological variables will also be evaluated, especially the development of adverse effects assessed according to the Clavien scale and the Comprehensive Complication Index. Following the literature, we assume an incidence of AUR of 11% and a margin of non-inferiority (delta) of 8% and estimate that a sample size of 208 patients per group will be required (with an estimated 10% of losses per group). Conclusions: In this study we try to demonstrate that the bladder catheter can be removed immediately after scheduled laparoscopic colon surgery, without increasing acute urine retention. This measure would offers the benefits of earlier mobilization and reduces catheter-related morbidity.
Nota:	This study has obtained a grant from the Spanish Association of Coloproctology (AECP), 2020.
Nota:	We thank all the members of our hospital's multidisciplinary committee for colorectal tumour assessment for their support, and the Parc Taulí Research Foundation for supervising the study from a methodological and statistical point of view. We are grateful to the surgical nurses Mercedes Muñoz, Mercedes Hernandez and Michael Maudsley for their help with English.
Derechos:	Aquest material està protegit per drets d'autor i/o drets afins. Podeu utilitzar aquest material en funció del que permet la legislació de drets d'autor i drets afins d'aplicació al vostre cas. Per a d'altres usos heu d'obtenir permís del(s) titular(s) de drets.
Lengua:	Anglès
Documento:	Article ; recerca ; Versió acceptada per publicar
Materia:	Acute urine retention ; Bladder catheter ; Laparoscopic colon
Publicado en:	Colorectal Disease, Vol. 25 Núm. 7 (july 2023) , p. 1506-1511, ISSN 1463-1318

DOI: 10.1111/codi.16593

Postprint 24 p, 583.8 KB

El registro aparece en las colecciones:
Documentos de investigación > Documentos de los grupos de investigación de la UAB > Centros y grupos de investigación (producción científica) > Ciencias de la salud y biociencias > Instituto de Investigación e Innovación Parc Taulí (I3PT)
Artículos > Artículos de investigación
Artículos > Artículos publicados