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Does caffeine reduce postoperative bowel paralysis after elective laparoscopic colectomy? (CaCo trial): study protocol for a randomized controlled trial

BACKGROUND: Postoperative bowel paralysis is common after abdominal operations, including colectomy. As a result, hospitalization may be prolonged, thereby leading to increased cost. A recent randomized controlled trial showed that the consumption of regular black coffee after colectomy is associate...

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Autores principales: Kruse, Christina, Müller, Sascha A., Warschkow, René, Lüthi, Cornelia, Brunner, Walter, Marti, Lukas, Sulz, Michael Christian, Schmied, Bruno M., Tarantino, Ignazio, Beutner, Ulrich
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4820979/
https://www.ncbi.nlm.nih.gov/pubmed/27044596
http://dx.doi.org/10.1186/s13063-016-1297-1
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author Kruse, Christina
Müller, Sascha A.
Warschkow, René
Lüthi, Cornelia
Brunner, Walter
Marti, Lukas
Sulz, Michael Christian
Schmied, Bruno M.
Tarantino, Ignazio
Beutner, Ulrich
author_facet Kruse, Christina
Müller, Sascha A.
Warschkow, René
Lüthi, Cornelia
Brunner, Walter
Marti, Lukas
Sulz, Michael Christian
Schmied, Bruno M.
Tarantino, Ignazio
Beutner, Ulrich
author_sort Kruse, Christina
collection PubMed
description BACKGROUND: Postoperative bowel paralysis is common after abdominal operations, including colectomy. As a result, hospitalization may be prolonged, thereby leading to increased cost. A recent randomized controlled trial showed that the consumption of regular black coffee after colectomy is associated with a significantly faster resumption of intestinal motility. The mechanism by which coffee stimulates intestinal motility is unknown, but caffeine seems to be the most likely stimulating agent. Thus, the effect of caffeine on postoperative bowel activity after colon surgery will be analyzed in this trial, herein referred to as CaCo. METHODS/DESIGN: Patients scheduled for elective laparoscopic colectomy or upper rectum resection are eligible to participate in this double-blinded, placebo-controlled, randomized trial. Patients fulfilling all inclusion criteria will be allocated after the surgical procedure to one of three treatment arms: 100 mg caffeine, 200 mg caffeine, or placebo (corn starch). Patients will take the capsules containing the study medication three times daily with a meal. The primary endpoint of the study is the time to a solid bowel movement. The study treatment will be stopped after the patient produces a solid bowel movement or has taken ten capsules, whichever occurs first. To determine the colonic passage time, patients will take a capsule with radiopaque markers at breakfast for the first 3 days after surgery. On the fourth day, the location of the markers will be determined with an abdominal X-ray scan. Further secondary objectives are the postoperative morbidity and mortality, well-being, sleeping behavior, and length of hospital stay. The study size was calculated to be 180 patients with an interim analysis occurring after 60 patients. DISCUSSION: From a previous study investigating coffee, evidence exists that caffeine might have a positive influence on the postoperative bowel activity. This double-blinded, placebo-controlled, randomized trial tries to show that caffeine will shorten the postoperative bowel paralysis and, thus, will improve recovery and shorten the hospital stay after colon surgery. TRIAL REGISTRATION: Clinicaltrials.gov NCT02510911 Swiss National Clinical Trials Portal SNCTP000001131 ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-016-1297-1) contains supplementary material, which is available to authorized users.
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spelling pubmed-48209792016-04-06 Does caffeine reduce postoperative bowel paralysis after elective laparoscopic colectomy? (CaCo trial): study protocol for a randomized controlled trial Kruse, Christina Müller, Sascha A. Warschkow, René Lüthi, Cornelia Brunner, Walter Marti, Lukas Sulz, Michael Christian Schmied, Bruno M. Tarantino, Ignazio Beutner, Ulrich Trials Study Protocol BACKGROUND: Postoperative bowel paralysis is common after abdominal operations, including colectomy. As a result, hospitalization may be prolonged, thereby leading to increased cost. A recent randomized controlled trial showed that the consumption of regular black coffee after colectomy is associated with a significantly faster resumption of intestinal motility. The mechanism by which coffee stimulates intestinal motility is unknown, but caffeine seems to be the most likely stimulating agent. Thus, the effect of caffeine on postoperative bowel activity after colon surgery will be analyzed in this trial, herein referred to as CaCo. METHODS/DESIGN: Patients scheduled for elective laparoscopic colectomy or upper rectum resection are eligible to participate in this double-blinded, placebo-controlled, randomized trial. Patients fulfilling all inclusion criteria will be allocated after the surgical procedure to one of three treatment arms: 100 mg caffeine, 200 mg caffeine, or placebo (corn starch). Patients will take the capsules containing the study medication three times daily with a meal. The primary endpoint of the study is the time to a solid bowel movement. The study treatment will be stopped after the patient produces a solid bowel movement or has taken ten capsules, whichever occurs first. To determine the colonic passage time, patients will take a capsule with radiopaque markers at breakfast for the first 3 days after surgery. On the fourth day, the location of the markers will be determined with an abdominal X-ray scan. Further secondary objectives are the postoperative morbidity and mortality, well-being, sleeping behavior, and length of hospital stay. The study size was calculated to be 180 patients with an interim analysis occurring after 60 patients. DISCUSSION: From a previous study investigating coffee, evidence exists that caffeine might have a positive influence on the postoperative bowel activity. This double-blinded, placebo-controlled, randomized trial tries to show that caffeine will shorten the postoperative bowel paralysis and, thus, will improve recovery and shorten the hospital stay after colon surgery. TRIAL REGISTRATION: Clinicaltrials.gov NCT02510911 Swiss National Clinical Trials Portal SNCTP000001131 ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-016-1297-1) contains supplementary material, which is available to authorized users. BioMed Central 2016-04-04 /pmc/articles/PMC4820979/ /pubmed/27044596 http://dx.doi.org/10.1186/s13063-016-1297-1 Text en © Kruse et al. 2016 Open AccessThis 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. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Kruse, Christina
Müller, Sascha A.
Warschkow, René
Lüthi, Cornelia
Brunner, Walter
Marti, Lukas
Sulz, Michael Christian
Schmied, Bruno M.
Tarantino, Ignazio
Beutner, Ulrich
Does caffeine reduce postoperative bowel paralysis after elective laparoscopic colectomy? (CaCo trial): study protocol for a randomized controlled trial
title Does caffeine reduce postoperative bowel paralysis after elective laparoscopic colectomy? (CaCo trial): study protocol for a randomized controlled trial
title_full Does caffeine reduce postoperative bowel paralysis after elective laparoscopic colectomy? (CaCo trial): study protocol for a randomized controlled trial
title_fullStr Does caffeine reduce postoperative bowel paralysis after elective laparoscopic colectomy? (CaCo trial): study protocol for a randomized controlled trial
title_full_unstemmed Does caffeine reduce postoperative bowel paralysis after elective laparoscopic colectomy? (CaCo trial): study protocol for a randomized controlled trial
title_short Does caffeine reduce postoperative bowel paralysis after elective laparoscopic colectomy? (CaCo trial): study protocol for a randomized controlled trial
title_sort does caffeine reduce postoperative bowel paralysis after elective laparoscopic colectomy? (caco trial): study protocol for a randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4820979/
https://www.ncbi.nlm.nih.gov/pubmed/27044596
http://dx.doi.org/10.1186/s13063-016-1297-1
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