A randomized, controlled trial of oral sulfate solution plus polyethylene glycol as a bowel preparation for colonoscopy

Douglas Rex, John McGowan, Mark Vb Cleveland, Jack A. Di Palma

Research output: Contribution to journalArticle

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Abstract

Background No bowel preparation for colonoscopy is optimal with regard to efficacy, safety, and tolerability. New options for bowel preparation are needed. Objective To compare a new hybrid preparation consisting of a reduced dose of oral sulfate solution (OSS) plus 2 L of sulfate-free electrolyte lavage solution (SF-ELS) with 2 low-volume preparations based on polyethylene glycol electrolyte lavage solution (PEG-ELS). Design Two randomized, controlled trials. Setting Twenty-four U.S. centers. Patients A total of 737 outpatients undergoing colonoscopy. Interventions In study 1, OSS plus SF-ELS was given as a split dose, and in study 2, OSS plus SF-ELS was given in its entirety the evening before colonoscopy. In study 1, the active control was 2 L of PEG-ELS plus ascorbic acid (PEG-EA) given as a split dose. In study 2, the control was 10 mg of bisacodyl plus 2 L of SF-ELS taken the evening before colonoscopy. Main Outcome Measurements Rates of successful (good or excellent) bowel preparation. Results In study 1, the rates of successful (excellent or good) preparation with OSS plus SF-ELS and PEG-EA were identical at 93.5% for split-dose preparation. OSS plus SF-ELS was noninferior to PEG-EA (P <.001). In study 2, OSS plus SF-ELS resulted in successful preparation in 89.8% of patients compared with 83.5% with bisacodyl plus SF-ELS in a same-day preparation regimen. OSS plus SF-ELS was noninferior to bisacodyl plus SF-ELS (P <.001). In study 1, vomiting was more frequent with OSS plus SF-ELS (13.5% vs 6.7%; P =.042), and bloating was rated worse with PEG-EA (P =.025). In study 2, overall discomfort was rated worse with OSS plus SF-ELS (mean score 2.1 vs 1.8; P =.032). There were no deaths in either study and no serious adverse events considered related to the preparation. Limitations Bowel cleansing was not scored by colon segment. Adenoma detection was not compared between the regimens. Conclusion OSS plus SF-ELS is a new, safe, and effective bowel preparation for colonoscopy.

Original languageEnglish
Pages (from-to)482-491
Number of pages10
JournalGastrointestinal Endoscopy
Volume80
Issue number3
DOIs
StatePublished - 2014

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Colonoscopy
Sulfates
Randomized Controlled Trials
Therapeutic Irrigation
Electrolytes
Bisacodyl
Ascorbic Acid

Keywords

  • Abbreviations
  • analysis of variance
  • ANOVA
  • CMH
  • Cochran-Mantel-Haenszel
  • FDA
  • intent-to-treat
  • ITT
  • oral sulfate solution
  • OSS
  • PEG-EA
  • PEG-ELS
  • polyethylene glycol electrolyte lavage solution
  • polyethylene glycol electrolyte lavage solution with ascorbic acid
  • SF-ELS
  • sulfate-free electrolyte lavage solution
  • U.S. Food and Drug Administration

ASJC Scopus subject areas

  • Gastroenterology
  • Radiology Nuclear Medicine and imaging
  • Medicine(all)

Cite this

A randomized, controlled trial of oral sulfate solution plus polyethylene glycol as a bowel preparation for colonoscopy. / Rex, Douglas; McGowan, John; Cleveland, Mark Vb; Di Palma, Jack A.

In: Gastrointestinal Endoscopy, Vol. 80, No. 3, 2014, p. 482-491.

Research output: Contribution to journalArticle

Rex, Douglas ; McGowan, John ; Cleveland, Mark Vb ; Di Palma, Jack A. / A randomized, controlled trial of oral sulfate solution plus polyethylene glycol as a bowel preparation for colonoscopy. In: Gastrointestinal Endoscopy. 2014 ; Vol. 80, No. 3. pp. 482-491.
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AU - Rex, Douglas

AU - McGowan, John

AU - Cleveland, Mark Vb

AU - Di Palma, Jack A.

PY - 2014

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N2 - Background No bowel preparation for colonoscopy is optimal with regard to efficacy, safety, and tolerability. New options for bowel preparation are needed. Objective To compare a new hybrid preparation consisting of a reduced dose of oral sulfate solution (OSS) plus 2 L of sulfate-free electrolyte lavage solution (SF-ELS) with 2 low-volume preparations based on polyethylene glycol electrolyte lavage solution (PEG-ELS). Design Two randomized, controlled trials. Setting Twenty-four U.S. centers. Patients A total of 737 outpatients undergoing colonoscopy. Interventions In study 1, OSS plus SF-ELS was given as a split dose, and in study 2, OSS plus SF-ELS was given in its entirety the evening before colonoscopy. In study 1, the active control was 2 L of PEG-ELS plus ascorbic acid (PEG-EA) given as a split dose. In study 2, the control was 10 mg of bisacodyl plus 2 L of SF-ELS taken the evening before colonoscopy. Main Outcome Measurements Rates of successful (good or excellent) bowel preparation. Results In study 1, the rates of successful (excellent or good) preparation with OSS plus SF-ELS and PEG-EA were identical at 93.5% for split-dose preparation. OSS plus SF-ELS was noninferior to PEG-EA (P <.001). In study 2, OSS plus SF-ELS resulted in successful preparation in 89.8% of patients compared with 83.5% with bisacodyl plus SF-ELS in a same-day preparation regimen. OSS plus SF-ELS was noninferior to bisacodyl plus SF-ELS (P <.001). In study 1, vomiting was more frequent with OSS plus SF-ELS (13.5% vs 6.7%; P =.042), and bloating was rated worse with PEG-EA (P =.025). In study 2, overall discomfort was rated worse with OSS plus SF-ELS (mean score 2.1 vs 1.8; P =.032). There were no deaths in either study and no serious adverse events considered related to the preparation. Limitations Bowel cleansing was not scored by colon segment. Adenoma detection was not compared between the regimens. Conclusion OSS plus SF-ELS is a new, safe, and effective bowel preparation for colonoscopy.

AB - Background No bowel preparation for colonoscopy is optimal with regard to efficacy, safety, and tolerability. New options for bowel preparation are needed. Objective To compare a new hybrid preparation consisting of a reduced dose of oral sulfate solution (OSS) plus 2 L of sulfate-free electrolyte lavage solution (SF-ELS) with 2 low-volume preparations based on polyethylene glycol electrolyte lavage solution (PEG-ELS). Design Two randomized, controlled trials. Setting Twenty-four U.S. centers. Patients A total of 737 outpatients undergoing colonoscopy. Interventions In study 1, OSS plus SF-ELS was given as a split dose, and in study 2, OSS plus SF-ELS was given in its entirety the evening before colonoscopy. In study 1, the active control was 2 L of PEG-ELS plus ascorbic acid (PEG-EA) given as a split dose. In study 2, the control was 10 mg of bisacodyl plus 2 L of SF-ELS taken the evening before colonoscopy. Main Outcome Measurements Rates of successful (good or excellent) bowel preparation. Results In study 1, the rates of successful (excellent or good) preparation with OSS plus SF-ELS and PEG-EA were identical at 93.5% for split-dose preparation. OSS plus SF-ELS was noninferior to PEG-EA (P <.001). In study 2, OSS plus SF-ELS resulted in successful preparation in 89.8% of patients compared with 83.5% with bisacodyl plus SF-ELS in a same-day preparation regimen. OSS plus SF-ELS was noninferior to bisacodyl plus SF-ELS (P <.001). In study 1, vomiting was more frequent with OSS plus SF-ELS (13.5% vs 6.7%; P =.042), and bloating was rated worse with PEG-EA (P =.025). In study 2, overall discomfort was rated worse with OSS plus SF-ELS (mean score 2.1 vs 1.8; P =.032). There were no deaths in either study and no serious adverse events considered related to the preparation. Limitations Bowel cleansing was not scored by colon segment. Adenoma detection was not compared between the regimens. Conclusion OSS plus SF-ELS is a new, safe, and effective bowel preparation for colonoscopy.

KW - Abbreviations

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KW - ANOVA

KW - CMH

KW - Cochran-Mantel-Haenszel

KW - FDA

KW - intent-to-treat

KW - ITT

KW - oral sulfate solution

KW - OSS

KW - PEG-EA

KW - PEG-ELS

KW - polyethylene glycol electrolyte lavage solution

KW - polyethylene glycol electrolyte lavage solution with ascorbic acid

KW - SF-ELS

KW - sulfate-free electrolyte lavage solution

KW - U.S. Food and Drug Administration

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