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PHaLIR: prevent hernia after loop ileostomy reversal—a study protocol for a randomized controlled multicenter study

BACKGROUND: Rectal cancer is a common cancer worldwide. Surgery for rectal cancer with low anterior resection often includes the formation of a temporary protective loop ileostomy. The temporary ostomy is later reversed in a separate operation. One complication following stoma closure is the develop...

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Autores principales: Eklöv, Karolina, Bringman, Sven, Löfgren, Jenny, Nygren, Jonas, Everhov, Åsa H.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10486037/
https://www.ncbi.nlm.nih.gov/pubmed/37684648
http://dx.doi.org/10.1186/s13063-023-07430-w
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author Eklöv, Karolina
Bringman, Sven
Löfgren, Jenny
Nygren, Jonas
Everhov, Åsa H.
author_facet Eklöv, Karolina
Bringman, Sven
Löfgren, Jenny
Nygren, Jonas
Everhov, Åsa H.
author_sort Eklöv, Karolina
collection PubMed
description BACKGROUND: Rectal cancer is a common cancer worldwide. Surgery for rectal cancer with low anterior resection often includes the formation of a temporary protective loop ileostomy. The temporary ostomy is later reversed in a separate operation. One complication following stoma closure is the development of a hernia at the former stoma site, and this has been reported in 7–15% of patients. The best method to avoid hernia after stoma closure is unclear. The most common closure is by suturing only, but different forms of mesh have been tried. Biological mesh has in a randomized trial halved hernia incidence after stoma reversal. Biosynthetic mesh and retromuscular mesh are currently being evaluated in ongoing studies. METHODS: The present multicenter, double-blinded, randomized, controlled study will compare standard suture closure of the abdominal wall in loop ileostomy reversal with retromuscular synthetic mesh at the stoma site. The study has been approved by the Regional Ethical Review board in Stockholm. Patients aged 18–90 years, operated on with low anterior resection and a protective loop ileostomy for rectal cancer and planned for ileostomy reversal, will be considered for inclusion in the study. Randomization will be 1:1 on the operation day with concealed envelopes. The estimated sample size is intended to evaluate the superiority of the experimental arm and to detect a reduction of hernia occurrence from 12 to 3%. The operation method is blinded to the patients and in the chart and for the observer at the 30-day follow-up. The main outcome is hernia occurrence at the stoma site within 3 years postoperatively, diagnosed through CT with strain. Secondary outcomes are operation time, length of hospital stay, pain, and 30-day complications. DISCUSSION: This double-blinded randomized controlled superiority study will compare retromuscular synthetic mesh during the closure of loop ileostomy to standard care. If this study can show a lower frequency of hernia with the use of prophylactic mesh, it may lead to new surgical guidelines during stoma closure. TRIAL REGISTRATION: ClinicalTrials.gov NCT03720262. Registered on October 25, 2018. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-023-07430-w.
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spelling pubmed-104860372023-09-09 PHaLIR: prevent hernia after loop ileostomy reversal—a study protocol for a randomized controlled multicenter study Eklöv, Karolina Bringman, Sven Löfgren, Jenny Nygren, Jonas Everhov, Åsa H. Trials Study Protocol BACKGROUND: Rectal cancer is a common cancer worldwide. Surgery for rectal cancer with low anterior resection often includes the formation of a temporary protective loop ileostomy. The temporary ostomy is later reversed in a separate operation. One complication following stoma closure is the development of a hernia at the former stoma site, and this has been reported in 7–15% of patients. The best method to avoid hernia after stoma closure is unclear. The most common closure is by suturing only, but different forms of mesh have been tried. Biological mesh has in a randomized trial halved hernia incidence after stoma reversal. Biosynthetic mesh and retromuscular mesh are currently being evaluated in ongoing studies. METHODS: The present multicenter, double-blinded, randomized, controlled study will compare standard suture closure of the abdominal wall in loop ileostomy reversal with retromuscular synthetic mesh at the stoma site. The study has been approved by the Regional Ethical Review board in Stockholm. Patients aged 18–90 years, operated on with low anterior resection and a protective loop ileostomy for rectal cancer and planned for ileostomy reversal, will be considered for inclusion in the study. Randomization will be 1:1 on the operation day with concealed envelopes. The estimated sample size is intended to evaluate the superiority of the experimental arm and to detect a reduction of hernia occurrence from 12 to 3%. The operation method is blinded to the patients and in the chart and for the observer at the 30-day follow-up. The main outcome is hernia occurrence at the stoma site within 3 years postoperatively, diagnosed through CT with strain. Secondary outcomes are operation time, length of hospital stay, pain, and 30-day complications. DISCUSSION: This double-blinded randomized controlled superiority study will compare retromuscular synthetic mesh during the closure of loop ileostomy to standard care. If this study can show a lower frequency of hernia with the use of prophylactic mesh, it may lead to new surgical guidelines during stoma closure. TRIAL REGISTRATION: ClinicalTrials.gov NCT03720262. Registered on October 25, 2018. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-023-07430-w. BioMed Central 2023-09-08 /pmc/articles/PMC10486037/ /pubmed/37684648 http://dx.doi.org/10.1186/s13063-023-07430-w Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Eklöv, Karolina
Bringman, Sven
Löfgren, Jenny
Nygren, Jonas
Everhov, Åsa H.
PHaLIR: prevent hernia after loop ileostomy reversal—a study protocol for a randomized controlled multicenter study
title PHaLIR: prevent hernia after loop ileostomy reversal—a study protocol for a randomized controlled multicenter study
title_full PHaLIR: prevent hernia after loop ileostomy reversal—a study protocol for a randomized controlled multicenter study
title_fullStr PHaLIR: prevent hernia after loop ileostomy reversal—a study protocol for a randomized controlled multicenter study
title_full_unstemmed PHaLIR: prevent hernia after loop ileostomy reversal—a study protocol for a randomized controlled multicenter study
title_short PHaLIR: prevent hernia after loop ileostomy reversal—a study protocol for a randomized controlled multicenter study
title_sort phalir: prevent hernia after loop ileostomy reversal—a study protocol for a randomized controlled multicenter study
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10486037/
https://www.ncbi.nlm.nih.gov/pubmed/37684648
http://dx.doi.org/10.1186/s13063-023-07430-w
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