Cargando…

Effect of prucalopride to improve time to gut function recovery following elective colorectal surgery: randomized clinical trial( )

BACKGROUND: Delayed return to gut function and prolonged postoperative ileus (PPOI) delay recovery after colorectal surgery. Prucalopride is a selective serotonin-4-receptor agonist that may improve gut motility. METHODS: This was a multicentre, double-blind, parallel, placebo-controlled randomized...

Descripción completa

Detalles Bibliográficos
Autores principales: Milne, Tony, Liu, Chen, O’Grady, Greg, Woodfield, John, Bissett, Ian
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10364744/
https://www.ncbi.nlm.nih.gov/pubmed/35639621
http://dx.doi.org/10.1093/bjs/znac121
_version_ 1785076908649611264
author Milne, Tony
Liu, Chen
O’Grady, Greg
Woodfield, John
Bissett, Ian
author_facet Milne, Tony
Liu, Chen
O’Grady, Greg
Woodfield, John
Bissett, Ian
author_sort Milne, Tony
collection PubMed
description BACKGROUND: Delayed return to gut function and prolonged postoperative ileus (PPOI) delay recovery after colorectal surgery. Prucalopride is a selective serotonin-4-receptor agonist that may improve gut motility. METHODS: This was a multicentre, double-blind, parallel, placebo-controlled randomized trial of 2 mg prucalopride versus placebo in patients undergoing elective colorectal resection. Patients with inflammatory bowel disease and planned ileostomy formation were excluded, but colostomy formation was allowed. The study medication was given 2 h before surgery and daily for up to 6 days after operation. The aim was to determine whether prucalopride improved return of gut function and reduced the incidence of PPOI. The primary endpoint was time to passage of stool and tolerance of diet (GI-2). Participants were allocated in a 1 : 1 ratio, in blocks of 10. Randomization was computer-generated. All study personnel, medical staff, and patients were blinded. RESULTS: This study was completed between October 2017 and May 2020 at two tertiary hospitals in New Zealand. A total of 148 patients were randomized, 74 per arm. Demographic data were similar in the two groups. There was no difference in median time to GI-2 between prucalopride and placebo groups: 3.5 (i.q.r. 2–5) versus 4 (3–5) days respectively (P = 0.124). Prucalopride improved the median time to passage of stool (3 versus 4 days; P = 0.027) but not time to tolerance of diet (2 versus 2 days; P = 0.669) or median duration of hospital stay (4 versus 4 days; P = 0.929). In patients who underwent laparoscopic surgery (125, 84.5 per cent), prucalopride improved median time to GI-2: 3 (2–4) days versus 4 (3–5) days for placebo (P = 0.012). The rate of PPOI, complications, and adverse events was similar in the two groups. CONCLUSION: Prucalopride did not improve time to overall recovery of gut function after elective colorectal surgery. Registration number: NCT02947269 (http://www.clinicaltrials.gov).
format Online
Article
Text
id pubmed-10364744
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher Oxford University Press
record_format MEDLINE/PubMed
spelling pubmed-103647442023-07-31 Effect of prucalopride to improve time to gut function recovery following elective colorectal surgery: randomized clinical trial( ) Milne, Tony Liu, Chen O’Grady, Greg Woodfield, John Bissett, Ian Br J Surg Randomized Clinical Trial BACKGROUND: Delayed return to gut function and prolonged postoperative ileus (PPOI) delay recovery after colorectal surgery. Prucalopride is a selective serotonin-4-receptor agonist that may improve gut motility. METHODS: This was a multicentre, double-blind, parallel, placebo-controlled randomized trial of 2 mg prucalopride versus placebo in patients undergoing elective colorectal resection. Patients with inflammatory bowel disease and planned ileostomy formation were excluded, but colostomy formation was allowed. The study medication was given 2 h before surgery and daily for up to 6 days after operation. The aim was to determine whether prucalopride improved return of gut function and reduced the incidence of PPOI. The primary endpoint was time to passage of stool and tolerance of diet (GI-2). Participants were allocated in a 1 : 1 ratio, in blocks of 10. Randomization was computer-generated. All study personnel, medical staff, and patients were blinded. RESULTS: This study was completed between October 2017 and May 2020 at two tertiary hospitals in New Zealand. A total of 148 patients were randomized, 74 per arm. Demographic data were similar in the two groups. There was no difference in median time to GI-2 between prucalopride and placebo groups: 3.5 (i.q.r. 2–5) versus 4 (3–5) days respectively (P = 0.124). Prucalopride improved the median time to passage of stool (3 versus 4 days; P = 0.027) but not time to tolerance of diet (2 versus 2 days; P = 0.669) or median duration of hospital stay (4 versus 4 days; P = 0.929). In patients who underwent laparoscopic surgery (125, 84.5 per cent), prucalopride improved median time to GI-2: 3 (2–4) days versus 4 (3–5) days for placebo (P = 0.012). The rate of PPOI, complications, and adverse events was similar in the two groups. CONCLUSION: Prucalopride did not improve time to overall recovery of gut function after elective colorectal surgery. Registration number: NCT02947269 (http://www.clinicaltrials.gov). Oxford University Press 2022-05-26 /pmc/articles/PMC10364744/ /pubmed/35639621 http://dx.doi.org/10.1093/bjs/znac121 Text en © The Author(s) 2022. Published by Oxford University Press on behalf of BJS Society Ltd. https://creativecommons.org/licenses/by/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Randomized Clinical Trial
Milne, Tony
Liu, Chen
O’Grady, Greg
Woodfield, John
Bissett, Ian
Effect of prucalopride to improve time to gut function recovery following elective colorectal surgery: randomized clinical trial( )
title Effect of prucalopride to improve time to gut function recovery following elective colorectal surgery: randomized clinical trial( )
title_full Effect of prucalopride to improve time to gut function recovery following elective colorectal surgery: randomized clinical trial( )
title_fullStr Effect of prucalopride to improve time to gut function recovery following elective colorectal surgery: randomized clinical trial( )
title_full_unstemmed Effect of prucalopride to improve time to gut function recovery following elective colorectal surgery: randomized clinical trial( )
title_short Effect of prucalopride to improve time to gut function recovery following elective colorectal surgery: randomized clinical trial( )
title_sort effect of prucalopride to improve time to gut function recovery following elective colorectal surgery: randomized clinical trial( )
topic Randomized Clinical Trial
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10364744/
https://www.ncbi.nlm.nih.gov/pubmed/35639621
http://dx.doi.org/10.1093/bjs/znac121
work_keys_str_mv AT milnetony effectofprucalopridetoimprovetimetogutfunctionrecoveryfollowingelectivecolorectalsurgeryrandomizedclinicaltrial
AT liuchen effectofprucalopridetoimprovetimetogutfunctionrecoveryfollowingelectivecolorectalsurgeryrandomizedclinicaltrial
AT ogradygreg effectofprucalopridetoimprovetimetogutfunctionrecoveryfollowingelectivecolorectalsurgeryrandomizedclinicaltrial
AT woodfieldjohn effectofprucalopridetoimprovetimetogutfunctionrecoveryfollowingelectivecolorectalsurgeryrandomizedclinicaltrial
AT bissettian effectofprucalopridetoimprovetimetogutfunctionrecoveryfollowingelectivecolorectalsurgeryrandomizedclinicaltrial