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Treatment of postoperative ileus with choline citrate—results of a prospective, randomised, placebo-controlled, double-blind multicentre trial

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International Journal of Colorectal Disease Aims and scope Submit manuscript

Abstract

Objectives

This was a prospective, randomised, placebo-controlled, double-blind multicentre trial to analyse the efficacy of choline citrate in patients with postoperative ileus (POI) after elective colorectal surgery.

Methods

From October 2005 until June 2008, 122 patients with POI were randomised to receive choline citrate or placebo. One hundred twenty patients were evaluable for tolerability and 107 patients were evaluable for efficacy. The treatment group, 47% (50/107), received 300.2 mg choline citrate intravenously, while the placebo group, 53% (57/107), received sodium chloride. Injections were performed every 12 h until defecation.

Results

Demographic data analysis did not show clinically differences between both groups. Operative procedures included 40% (43/107) hemicolectomy, 38% (41/107) sigmoid resection and 22% (23/107) other colorectal resections. Defecation occurred after an average of 91.8 ± 26.6 h postoperatively in the treatment group, vs. 96.7 ± 35.2 h in the placebo group (p = 0.805). After laparoscopy, defecation occurred after 78.7 ± 25.3 h, vs. 99.2 ± 31.6 h after laparotomy (p = 0.001). Serious adverse effects occurred in 2% (1/60) in the treatment group, vs. 3% (2/60) in the placebo group. None of the events have been assessed as related to the study medication.

Conclusion

An efficacy of choline citrate in the treatment of POI after elective colorectal surgery could not be verified. The problem of POI requiring drug treatment seems to be less frequent than suggested by the literature. With technical advances in surgery, especially laparoscopic and fast track surgery, the frequency of POI will further decrease in the future.

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Acknowledgments

The study was supported by the manufacturer of choline citrate (Neurotropan®), Phoenix Laboratorium, Germany, www.phoenix-lab.de.

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Authors and Affiliations

  1. Department of Surgery, St. Josef Hospital, Ruhr University Bochum, Gudrunstr. 56, 44791, Bochum, Germany

    Torsten Herzog & Waldemar Uhl

  2. Department of Surgery, Hospital Havelhöhe Berlin, Berlin, Germany

    Hans P. Lemmens

  3. Department of Surgery, Hospital Weissensee, Berlin, Germany

    Georg Arlt

  4. Department of Surgery, Vivantes Hospital am Urban, Berlin, Germany

    Roland Raakow

  5. Department of Surgery, St. Georg Hospital, Leipzig, Germany

    Arved Weimann

  6. Department of Surgery, Charité, Campus Virchow, Berlin, Germany

    Andreas Pascher

  7. Department of Surgery, University Hospital of Duesseldorf, Duesseldorf, Germany

    Wolfram T. Knoefel

  8. Department of Surgery, Hospital Bad Cannstadt, Stuttgart, Germany

    Uwe Hesse

  9. GKM, Munich, Germany

    Karl Scheithe & Susanne Groll

Authors
  1. Torsten Herzog
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  2. Hans P. Lemmens
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  3. Georg Arlt
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  4. Roland Raakow
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  5. Arved Weimann
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  6. Andreas Pascher
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  7. Wolfram T. Knoefel
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  8. Uwe Hesse
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  9. Karl Scheithe
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  10. Susanne Groll
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  11. Waldemar Uhl
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Corresponding author

Correspondence to Waldemar Uhl.

Additional information

Manuscript type: prospective, randomised, placebo-controlled, double-blind phase III trial

Trial registration study number: CC 0401, protocol version 6.0, July 7th, 2006

EUCRACT number: 2005-000182-19

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Herzog, T., Lemmens, H.P., Arlt, G. et al. Treatment of postoperative ileus with choline citrate—results of a prospective, randomised, placebo-controlled, double-blind multicentre trial. Int J Colorectal Dis 26, 645–652 (2011). https://doi.org/10.1007/s00384-010-1092-5

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  • DOI: https://doi.org/10.1007/s00384-010-1092-5

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