Phosphate tablets or polyethylene glycol for preparation to colonoscopy? A multicentre non-inferiority randomized controlled trial

Surg Endosc. 2017 May;31(5):2166-2173. doi: 10.1007/s00464-016-5214-1. Epub 2016 Nov 18.

Abstract

Background: Adequate bowel preparation is a crucial step in colonoscopy procedure and has been identified as the cornerstone of a quality colonoscopy. Polyethylene glycol (PEG) for bowel cleansing still had up to 10 % unprepared colon.

Aim: We herein compare efficacy, acceptability, tolerance and safety of sodium phosphate (NaP) tablets and split-dose PEG for bowel cleansing.

Patients and methods: A prospective non-inferiority randomized trial was performed and registered on www.clinicaltrials.gov (NCT01840553). Patients were randomized to either 32 NaP tablets or 4 L of PEG. Blind readers assessed the efficacy of colon cleansing using the Boston Bowel Preparation Scale (BBPS).

Results: A total of 461 patients were randomized in groups (NaP group: n = 231; PEG group: n = 230). Median age was 54 and 52 in NaP group and PEG group, respectively (p < 0.01). Patients experienced an overall compliance to the treatment in 99.6 and 94.1 % in the NaP group and in the PEG group, respectively (p < 0.001). The mean time of withdrawal was 15.1 ± 8.9 and 15.4 ± 9.5 min in the NaP group and in the PEG group, respectively (p = 0.95). The good quality of bowel preparation, defined as BBPS score ≥7, was obtained in 86.4 and 89.0 % of cases in the NaP group and in the PEG group, respectively (p = 0.42). In all segment (right colon, transverse colon and left colon and rectum), the NaP group was non-inferior to the PEG group. Bowel prep regimen was more frequently considered as "easy" by patients from the NaP group (54.8 % of patients) than patients from the PEG group (29.0 % of patients; p < 0.001). No serious adverse events were reported. No statistical differences were found between the NaP group and the PEG group concerning the incidence of an adverse event (338 vs. 322, respectively).

Conclusion: While NaP tablets appeared as efficient as PEG in terms of colon cleansing prior to a colonoscopy, they significantly improved the overall compliance and eased product administration. At an era where bowel cleansing appears to be the cornerstone of a quality colonoscopy, NaP tablets in patients without contraindication might be considered as an option.

Keywords: Boston score; Colonoscopy; PEG; Polyethylene glycol; Preparation; Sodium phosphate tablets.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Cathartics / administration & dosage*
  • Colonoscopy*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Patient Compliance
  • Patient Satisfaction
  • Phosphates / administration & dosage*
  • Polyethylene Glycols / administration & dosage*
  • Preoperative Care
  • Prospective Studies
  • Tablets

Substances

  • Cathartics
  • Phosphates
  • Tablets
  • Polyethylene Glycols
  • sodium phosphate

Associated data

  • ClinicalTrials.gov/NCT01840553