title: Treatment of postoperative ileus with choline citrate--results of a prospective, randomised, placebo-controlled, double-blind multicentre trial.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Surgery, St. Josef Hospital, Ruhr University Bochum, Gudrunstr. 56, 44791, Bochum, Germany.
authors.forename: Torsten
authors.initials: T
authors.lastname: Herzog
authors.forename: Hans P
authors.initials: HP
authors.lastname: Lemmens
authors.forename: Georg
authors.initials: G
authors.lastname: Arlt
authors.forename: Roland
authors.initials: R
authors.lastname: Raakow
authors.forename: Arved
authors.initials: A
authors.lastname: Weimann
authors.forename: Andreas
authors.initials: A
authors.lastname: Pascher
authors.forename: Wolfram T
authors.initials: WT
authors.lastname: Knoefel
authors.forename: Uwe
authors.initials: U
authors.lastname: Hesse
authors.forename: Karl
authors.initials: K
authors.lastname: Scheithe
authors.forename: Susanne
authors.initials: S
authors.lastname: Groll
authors.forename: Waldemar
authors.initials: W
authors.lastname: Uhl
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002794:Choline / Q000009:adverse effects / Q000627:therapeutic use*; D003710:Demography; D004311:Double-Blind Method; D023381:Endpoint Determination; D005260:Female; D006801:Humans; D045823:Ileus / Q000188:drug therapy* / Q000209:etiology*; D008082:Lipotropic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010919:Placebos; D011183:Postoperative Complications / Q000188:drug therapy* / Q000209:etiology*; D011446:Prospective Studies; D055815:Young Adult
chemical_list: D008082:Lipotropic Agents; D010919:Placebos; D002794:Choline