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Published in: Surgical Endoscopy 5/2017

01-05-2017

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

Authors: Stanislas Chaussade, Christoph Schmöcker, Pierre Toulemonde, Miguel Muñoz-Navas, Valérie O’Mahony, Franck Henri

Published in: Surgical Endoscopy | Issue 5/2017

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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.
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Metadata
Title
Phosphate tablets or polyethylene glycol for preparation to colonoscopy? A multicentre non-inferiority randomized controlled trial
Authors
Stanislas Chaussade
Christoph Schmöcker
Pierre Toulemonde
Miguel Muñoz-Navas
Valérie O’Mahony
Franck Henri
Publication date
01-05-2017
Publisher
Springer US
Published in
Surgical Endoscopy / Issue 5/2017
Print ISSN: 0930-2794
Electronic ISSN: 1432-2218
DOI
https://doi.org/10.1007/s00464-016-5214-1

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