The Bowel CLEANsing National Initiative: High-Volume Split-Dose Vs Low-Volume Split-Dose Polyethylene Glycol Preparations: A Randomized Controlled Trial

Alan N Barkun; Myriam Martel; Ian L Epstein; Pierre Hallé; Robert J Hilsden; Paul D James; Alaa Rostom; Michael Sey; Harminder Singh; Richard Sultanian; Jennifer J Telford; Daniel von Renteln

doi:10.1016/j.cgh.2021.09.005

The Bowel CLEANsing National Initiative: High-Volume Split-Dose Vs Low-Volume Split-Dose Polyethylene Glycol Preparations: A Randomized Controlled Trial

Clin Gastroenterol Hepatol. 2022 Jun;20(6):e1469-e1477. doi: 10.1016/j.cgh.2021.09.005. Epub 2021 Sep 9.

Authors

Affiliations

¹ Division of Gastroenterology, Department of Medicine, McGill University Health Center, McGill University, Montreal, Quebec, Canada. Electronic address: alan.barkun@muhc.mcgill.ca.
² Division of Gastroenterology, Department of Medicine, McGill University Health Center, McGill University, Montreal, Quebec, Canada.
³ Division of Digestive Care & Endoscopy, Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.
⁴ Division of Gastroenterology, Department of Medicine, University Hospital of Quebec-Université Laval, Québec, Canada.
⁵ Division of Gastroenterology and Hepatology, Department of Medicine, University of Calgary, Calgary, Alberta, Canada.
⁶ Division of Gastroenterology, Department of Medicine, University Health Network, Toronto, Ontario, Canada.
⁷ Division of Gastroenterology, Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
⁸ Division of Gastroenterology, Department of Medicine, Western University, London, Ontario, Canada.
⁹ Research Institute in Oncology and Hematology, CancerCare Manitoba and Department of Internal Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.
¹⁰ Division of Gastroenterology, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.
¹¹ Division of Gastroenterology, Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.
¹² Division of Gastroenterology, Department of Medicine, Université de Montréal, Montreal, Quebec, Canada.

PMID: 34509641
DOI: 10.1016/j.cgh.2021.09.005

Abstract

Background & aims: The aim of this study was to compare high-volume polyethylene glycol (PEG) with low-volume PEG with bisacodyl split-dosing regimens.

Methods: Adult outpatients in 10 Canadian tertiary hospitals were randomized, stratified by morning or afternoon colonoscopy, to high-volume split-dose PEG (2 L + 2 L) (High-SD) or low volume (1 L + 1 L) + bisacodyl (15 mg) PEG (Low-SD), with a second randomization to liquid or low-residue diets. The primary end point, using noninferiority hypothesis testing, was adequate bowel cleansing (Boston Bowel Preparation Scale total score of ≥6, with each of 3 colonic segments subscores ≥2). Secondary objectives were willingness to repeat the preparation, withdrawal time, cecal intubation, and polyp detection rates.

Results: Over 29 months, 2314 subjects were randomized to High-SD (N = 1157) or Low-SD (N = 1157) (mean age, 56.2 ± 13.4 y; 52.1% women). Colonoscopy indications were 38.2% diagnostic, 36.8% screening, and 25.0% surveillance, with no between-group imbalances in patient characteristics. Low-SD satisfied noninferiority criteria vs High-SD for adequate bowel cleanliness with only marginally inferior results (90.1% vs 88.1%; P = .02; difference, 2.0%; 95% CI [0.0%; 4.5%]). High-SD was associated with lower willingness to repeat (66.9% vs 91.9%; P < .01), was less well tolerated (7.3 ± 2.3 vs 8.1 ± 1.9; P < .01), causing more symptoms. No differences in procedural outcomes were noted except for more frequent cecal intubation rates after High-SD (97.4% vs 95.6%; P = .02). Among the High-SD group, adequate bowel preparation was greater after a clear liquid diet (93.6% vs 87.9%; P < .01), a finding not seen in the Low-SD group.

Conclusions: Low-SD is noninferior to High-SD in providing adequate bowel preparation. Low-SD results in fewer symptoms, with greater willingness to repeat and tolerability. The overall impact of diet was modest.The study was approved by the research ethic boards from all sites and was registered at ClinicalTrials.gov (NCT02547571).

Keywords: Bowel Preparation; Cecal Intubation; Colonoscopy; Polyp Detection; Willingness to Repeat.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Adult
Aged
Bisacodyl*
Canada
Cathartics* / adverse effects
Cecum
Colonoscopy / methods
Female
Humans
Male
Middle Aged
Polyethylene Glycols

Substances

Cathartics
Bisacodyl
Polyethylene Glycols

Associated data

ClinicalTrials.gov/NCT02547571