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Nicotine chewing gum for the prevention of postoperative ileus after colorectal surgery: a multicenter, double-blind, randomised, controlled pilot study

PURPOSE: When postoperative ileus is not resolved after 5 days or recurs after resolution, prolonged POI (PPOI) is diagnosed. PPOI increases discomfort, morbidity and hospitalisation length, and is mainly caused by an inflammatory response following intestinal manipulation. This response can be weak...

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Autores principales: Lambrichts, Daniël P. V., Boersema, Geesien S. A., Tas, Buket, Wu, Zhouqiao, Vrijland, Wietske W., Kleinrensink, Gert-Jan, Jeekel, Johannes, Lange, Johan F., Menon, Anand G.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Berlin Heidelberg 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5554272/
https://www.ncbi.nlm.nih.gov/pubmed/28660314
http://dx.doi.org/10.1007/s00384-017-2839-z
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author Lambrichts, Daniël P. V.
Boersema, Geesien S. A.
Tas, Buket
Wu, Zhouqiao
Vrijland, Wietske W.
Kleinrensink, Gert-Jan
Jeekel, Johannes
Lange, Johan F.
Menon, Anand G.
author_facet Lambrichts, Daniël P. V.
Boersema, Geesien S. A.
Tas, Buket
Wu, Zhouqiao
Vrijland, Wietske W.
Kleinrensink, Gert-Jan
Jeekel, Johannes
Lange, Johan F.
Menon, Anand G.
author_sort Lambrichts, Daniël P. V.
collection PubMed
description PURPOSE: When postoperative ileus is not resolved after 5 days or recurs after resolution, prolonged POI (PPOI) is diagnosed. PPOI increases discomfort, morbidity and hospitalisation length, and is mainly caused by an inflammatory response following intestinal manipulation. This response can be weakened by targeting the cholinergic anti-inflammatory pathway, with nicotine as essential regulator. Chewing gum, already known to stimulate gastrointestinal motility itself, combined with nicotine is hypothesised to improve gastrointestinal recovery and prevent PPOI. This pilot study is the first to assess efficacy and safety of nicotine gum in colorectal surgery. METHODS: Patients undergoing elective oncological colorectal surgery were enrolled in this double-blind, parallel-group, controlled trial and randomly assigned to a treatment protocol with normal or nicotine gum (2 mg). Patient reported outcomes (PROMS), clinical characteristics and blood samples were collected. Primary endpoint was defined as time to first passage of faeces and toleration of solid food for at least 24 h. RESULTS: In total, 40 patients were enrolled (20 vs. 20). In both groups, six patients developed PPOI. Time to primary endpoint (4.50 [3.00–7.25] vs. 3.50 days [3.00–4.25], p = 0.398) and length of stay (5.50 [4.00–8.50] vs. 4.50 days [4.00–6.00], p = 0.738) did not differ significantly between normal and nicotine gum. There were no differences in PROMS, inflammatory parameters and postoperative complications. CONCLUSIONS: We proved nicotine gum to be safe but ineffective in improving gastrointestinal recovery and prevention of PPOI after colorectal surgery. Other dosages and administration routes of nicotine should be tested in future research. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s00384-017-2839-z) contains supplementary material, which is available to authorized users.
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spelling pubmed-55542722017-08-25 Nicotine chewing gum for the prevention of postoperative ileus after colorectal surgery: a multicenter, double-blind, randomised, controlled pilot study Lambrichts, Daniël P. V. Boersema, Geesien S. A. Tas, Buket Wu, Zhouqiao Vrijland, Wietske W. Kleinrensink, Gert-Jan Jeekel, Johannes Lange, Johan F. Menon, Anand G. Int J Colorectal Dis Original Article PURPOSE: When postoperative ileus is not resolved after 5 days or recurs after resolution, prolonged POI (PPOI) is diagnosed. PPOI increases discomfort, morbidity and hospitalisation length, and is mainly caused by an inflammatory response following intestinal manipulation. This response can be weakened by targeting the cholinergic anti-inflammatory pathway, with nicotine as essential regulator. Chewing gum, already known to stimulate gastrointestinal motility itself, combined with nicotine is hypothesised to improve gastrointestinal recovery and prevent PPOI. This pilot study is the first to assess efficacy and safety of nicotine gum in colorectal surgery. METHODS: Patients undergoing elective oncological colorectal surgery were enrolled in this double-blind, parallel-group, controlled trial and randomly assigned to a treatment protocol with normal or nicotine gum (2 mg). Patient reported outcomes (PROMS), clinical characteristics and blood samples were collected. Primary endpoint was defined as time to first passage of faeces and toleration of solid food for at least 24 h. RESULTS: In total, 40 patients were enrolled (20 vs. 20). In both groups, six patients developed PPOI. Time to primary endpoint (4.50 [3.00–7.25] vs. 3.50 days [3.00–4.25], p = 0.398) and length of stay (5.50 [4.00–8.50] vs. 4.50 days [4.00–6.00], p = 0.738) did not differ significantly between normal and nicotine gum. There were no differences in PROMS, inflammatory parameters and postoperative complications. CONCLUSIONS: We proved nicotine gum to be safe but ineffective in improving gastrointestinal recovery and prevention of PPOI after colorectal surgery. Other dosages and administration routes of nicotine should be tested in future research. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s00384-017-2839-z) contains supplementary material, which is available to authorized users. Springer Berlin Heidelberg 2017-06-28 2017 /pmc/articles/PMC5554272/ /pubmed/28660314 http://dx.doi.org/10.1007/s00384-017-2839-z Text en © The Author(s) 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
spellingShingle Original Article
Lambrichts, Daniël P. V.
Boersema, Geesien S. A.
Tas, Buket
Wu, Zhouqiao
Vrijland, Wietske W.
Kleinrensink, Gert-Jan
Jeekel, Johannes
Lange, Johan F.
Menon, Anand G.
Nicotine chewing gum for the prevention of postoperative ileus after colorectal surgery: a multicenter, double-blind, randomised, controlled pilot study
title Nicotine chewing gum for the prevention of postoperative ileus after colorectal surgery: a multicenter, double-blind, randomised, controlled pilot study
title_full Nicotine chewing gum for the prevention of postoperative ileus after colorectal surgery: a multicenter, double-blind, randomised, controlled pilot study
title_fullStr Nicotine chewing gum for the prevention of postoperative ileus after colorectal surgery: a multicenter, double-blind, randomised, controlled pilot study
title_full_unstemmed Nicotine chewing gum for the prevention of postoperative ileus after colorectal surgery: a multicenter, double-blind, randomised, controlled pilot study
title_short Nicotine chewing gum for the prevention of postoperative ileus after colorectal surgery: a multicenter, double-blind, randomised, controlled pilot study
title_sort nicotine chewing gum for the prevention of postoperative ileus after colorectal surgery: a multicenter, double-blind, randomised, controlled pilot study
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5554272/
https://www.ncbi.nlm.nih.gov/pubmed/28660314
http://dx.doi.org/10.1007/s00384-017-2839-z
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