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Comparison of different durations of physical activity restrictions following incisional hernia repair in sublay technique, the 3N6 trial: A prospective clinical trial
BACKGROUND: Incisional hernias (IH) occur in 4 to 20% of cases following abdominal surgeries, often after laparotomies. In the US, there are 4 to 5 million laparotomies performed per year, which could lead to 400.000 to 1.000.000 IHs. Therefore, this disease accounts as an important social-economic...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7270603/ https://www.ncbi.nlm.nih.gov/pubmed/32518883 http://dx.doi.org/10.1016/j.isjp.2020.05.001 |
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author | Boettge, Katherina R. Croner, Roland Lefering, Rolf Lorenz, Eric Paasch, Christoph |
author_facet | Boettge, Katherina R. Croner, Roland Lefering, Rolf Lorenz, Eric Paasch, Christoph |
author_sort | Boettge, Katherina R. |
collection | PubMed |
description | BACKGROUND: Incisional hernias (IH) occur in 4 to 20% of cases following abdominal surgeries, often after laparotomies. In the US, there are 4 to 5 million laparotomies performed per year, which could lead to 400.000 to 1.000.000 IHs. Therefore, this disease accounts as an important social-economic factor. Furthermore, these hernias can lead to bowel incarcerations, chronic pain, and a decrease in quality of life. To guarantee sufficient wound healing and decrease the recurrence rate, physical activity restrictions (PAR) are recommended. The standard recommendations for PAR seem to vary from 0 to 12 weeks, but the evidence remains low due to a lack of clinical trials. Conducting the study at hand, we aim to provide more evidence on this topic. METHODS: The 3N6 trial will be conducted as a national multicenter prospective trial with two study groups (n = 90), where the goal is to find matched pairs within the two groups. Patients who underwent open incisional hernia repair (IHR) in sublay technique will be enrolled. A patient in the 3-week PAR group will be matched to a patient in the 6-week PAR group based on heavy lifting, male gender, BMI > 30, and large hernia >7 cm. The primary endpoint is the duration of sick leave that patients require to return to work, by comparing PAR of 6 weeks with PAR of 3 weeks. The secondary endpoints are the recurrence rate, seroma formation, and chronic pain one year after surgery and postoperative complications within 30 days using Clavien-Dindo-classification. DISSEMINATION: The findings will be published in a peer-reviewed journal. We may also present the findings at local and/or national conferences. |
format | Online Article Text |
id | pubmed-7270603 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Elsevier |
record_format | MEDLINE/PubMed |
spelling | pubmed-72706032020-06-08 Comparison of different durations of physical activity restrictions following incisional hernia repair in sublay technique, the 3N6 trial: A prospective clinical trial Boettge, Katherina R. Croner, Roland Lefering, Rolf Lorenz, Eric Paasch, Christoph Int J Surg Protoc Research Paper BACKGROUND: Incisional hernias (IH) occur in 4 to 20% of cases following abdominal surgeries, often after laparotomies. In the US, there are 4 to 5 million laparotomies performed per year, which could lead to 400.000 to 1.000.000 IHs. Therefore, this disease accounts as an important social-economic factor. Furthermore, these hernias can lead to bowel incarcerations, chronic pain, and a decrease in quality of life. To guarantee sufficient wound healing and decrease the recurrence rate, physical activity restrictions (PAR) are recommended. The standard recommendations for PAR seem to vary from 0 to 12 weeks, but the evidence remains low due to a lack of clinical trials. Conducting the study at hand, we aim to provide more evidence on this topic. METHODS: The 3N6 trial will be conducted as a national multicenter prospective trial with two study groups (n = 90), where the goal is to find matched pairs within the two groups. Patients who underwent open incisional hernia repair (IHR) in sublay technique will be enrolled. A patient in the 3-week PAR group will be matched to a patient in the 6-week PAR group based on heavy lifting, male gender, BMI > 30, and large hernia >7 cm. The primary endpoint is the duration of sick leave that patients require to return to work, by comparing PAR of 6 weeks with PAR of 3 weeks. The secondary endpoints are the recurrence rate, seroma formation, and chronic pain one year after surgery and postoperative complications within 30 days using Clavien-Dindo-classification. DISSEMINATION: The findings will be published in a peer-reviewed journal. We may also present the findings at local and/or national conferences. Elsevier 2020-05-23 /pmc/articles/PMC7270603/ /pubmed/32518883 http://dx.doi.org/10.1016/j.isjp.2020.05.001 Text en Published by Elsevier Ltd on behalf of Surgical Associates Ltd. http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). |
spellingShingle | Research Paper Boettge, Katherina R. Croner, Roland Lefering, Rolf Lorenz, Eric Paasch, Christoph Comparison of different durations of physical activity restrictions following incisional hernia repair in sublay technique, the 3N6 trial: A prospective clinical trial |
title | Comparison of different durations of physical activity restrictions following incisional hernia repair in sublay technique, the 3N6 trial: A prospective clinical trial |
title_full | Comparison of different durations of physical activity restrictions following incisional hernia repair in sublay technique, the 3N6 trial: A prospective clinical trial |
title_fullStr | Comparison of different durations of physical activity restrictions following incisional hernia repair in sublay technique, the 3N6 trial: A prospective clinical trial |
title_full_unstemmed | Comparison of different durations of physical activity restrictions following incisional hernia repair in sublay technique, the 3N6 trial: A prospective clinical trial |
title_short | Comparison of different durations of physical activity restrictions following incisional hernia repair in sublay technique, the 3N6 trial: A prospective clinical trial |
title_sort | comparison of different durations of physical activity restrictions following incisional hernia repair in sublay technique, the 3n6 trial: a prospective clinical trial |
topic | Research Paper |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7270603/ https://www.ncbi.nlm.nih.gov/pubmed/32518883 http://dx.doi.org/10.1016/j.isjp.2020.05.001 |
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