Comparison between different colon cleansing products for screening colonoscopy. A noninferiority trial in population-based screening programs in Italy

Endoscopy. 2016 Mar;48(3):223-31. doi: 10.1055/s-0035-1569574. Epub 2016 Jan 13.

Abstract

Background and study aims: The high volume and poor palatability of 4 L of polyethylene glycol (PEG)-based bowel cleansing preparation required before a colonoscopy represent a major obstacle for patients. The aim of this study was to compare two low volume PEG-based preparations with standard 4 L PEG in individuals with a positive fecal immunochemical test (FIT) within organized screening programs in Italy.

Patients and methods: A total of 3660 patients with a positive FIT result were randomized to receive, in a split-dose regimen, 4 L PEG or 2 L PEG plus ascorbate (PEG-A) or 2 L PEG with citrate and simethicone plus bisacodyl (PEG-CS). The noninferiority of the low volume preparations vs. 4 L PEG was tested through the difference in proportions of adequate cleansing.

Results: A total of 2802 patients were included in the study. Adequate bowel cleansing was achieved in 868 of 926 cases (93.7 %) in the 4 L PEG group, in 872 out of 911 cases in the PEG-A group (95.7 %, difference in proportions + 1.9 %, 95 % confidence interval [CI] - 0.1 to 3.9), and in 862 out of 921 cases in the PEG-CS group (93.6 %, difference in proportions - 0.2 %, 95 %CI - 2.4 to 2.0). Bowel cleansing was adequate in 95.5 % of cases when the preparation-to-colonoscopy interval was between 120 and 239 minutes, whereas it dropped to 83.3 % with longer intervals. Better cleansing was observed in patients with regular bowel movements (95.6 %) compared with those with diarrhea (92.4 %) or constipation (90.8 %).

Conclusion: Low volume PEG-based preparations administered in a split-dose regimen guarantee noninferior bowel cleansing compared with 4 L PEG. Constipated patients require a personalized preparation.

Trial registration: EudraCT 2012 - 003958 - 82.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Ascorbic Acid / administration & dosage
  • Bisacodyl / administration & dosage
  • Cathartics / administration & dosage*
  • Citric Acid / administration & dosage
  • Colonoscopy*
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Drug Therapy, Combination
  • Female
  • Humans
  • Italy
  • Male
  • Middle Aged
  • Outcome Assessment, Health Care
  • Polyethylene Glycols / administration & dosage
  • Simethicone / administration & dosage

Substances

  • Cathartics
  • Bisacodyl
  • Citric Acid
  • Polyethylene Glycols
  • Simethicone
  • Ascorbic Acid

Associated data

  • EudraCT/EUDRACT2012 - 003958 - 82