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ORIGINAL CONTRIBUTION: ENDOSCOPY

Randomized Trial of Low-Volume PEG SolutionVersus Standard PEG + Electrolytes for Bowel Cleansing Before Colonoscopy

Ell, Christian M.D., Ph.D.1; Fischbach, Wolfgang M.D., Ph.D.2; Bronisch, Hans-Joachim M.D.3; Dertinger, Stefan M.D.4; Layer, Peter M.D., Ph.D.5; Rünzi, Michael M.D.6; Schneider, Thomas M.D., Ph.,D.7; Kachel, Günther M.D.8; Grüger, Jörg M.D.9; Köllinger, Michael M.D.10; Nagell, Waltraud M.D.11; Goerg, Karl-Josel M.D.12; Wanitschke, Roland M.D., Ph.D.13; Gruss, Hans-Jürgen M.D.14

Author Information

1Dr. Horst Schmidt Kliniken GmbH, Wiesbaden, Germany;2Klinikum Aschaffenburg, Aschaffenburg, Germany;3Katholisches Krankenhaus St. Johann Nepomuk, Erfurt, Germany;4Kreiskrankenhaus Tirschenreuth, Tirschenreuth, Germany;5Israelitisches Krankenhaus, Hamburg, Germany;6Kliniken Essen-Süd–Katholisches Krankenhaus St. Josef gGmbH, Essen, Germany;7Klinikum Fürth, Fürth, Germany;8Klinikum Dachau, Dachau, Germany;9Städtische Kliniken Frankfurt-Höchst, Frankfurt/Main, Germany;10Klinikum St. Marien, Amberg, Germany;11Bürgerhospital Frankfurt am Main e.V., Frankfurt/Main, Germany;12Kliniken St. Antonius, Wuppertal, Germany;13Universitätsklinik Mainz, Mainz, Germany; and14Norgine Ltd., R&D Division, Harefield, United Kingdom

Reprint requests and correspondence: Christian Ell, Dr. Horst-Schmidt-Kliniken GmbH, Chefrzt Innere Medizin II, Ludwig-Erhard-Straße 100, D-65199 Wiesbaden, Germany.

CONFLICT OF INTEREST

Guarantor of the article: Christian Ell, M.D., Ph.D.

Specific author contributions: Conception and design: Ell, Fischbach, Layer, Wanitschke, and Gruss; acquisition of patient data: Ell, Fischbach, Bronisch, Dertinger, Layer, Rünzi, Schneider, Kachel, Grüger, Köllinger, and Nagell; expert colonoscopy review: Goerg and Wanitschke; analysis and interpretation: Ell, Fischbach, Layer, Wanitschke, and Gruss; manuscript draft: Ell and Gruss; and critical revision of the manuscript: all authors.

Financial support: This study was conducted and funded by Norgine Ltd.

Potential competing interests: Drs. Ell, Fischbach, Layer, Goerg, and Wanitscke are members of the Speakers Bureau of Norgine Ltd. Drs. Ell and Fischbach are paid advisory group consultants for Norgine Ltd. Dr. Gruss is an employee of Norgine Ltd.

Received March 26, 2007; accepted November 4, 2007.

American Journal of Gastroenterology103(4):p 883-893, April 2008.

Abstract

OBJECTIVES 

Polyethylene glycol (PEG)-based gut lavage solutions are safe and effective, but require consumption of large volumes of fluid. We compared a new 2 L solution of PEG plus ascorbic acid (PEG + Asc) with standard 4 L PEG with electrolytes (PEG + E) for bowel cleansing before colonoscopy to determine efficacy, safety, and patient acceptability.

METHODS 

Consenting adult inpatients scheduled to undergo colonoscopy were randomized to receive either 2 L PEG + Asc or 4 L PEG + E. Preparations were taken as split doses the evening before colonoscopy and the following morning. The PEG + Asc group took 1 L at each administration (i.e., total dose of 2 L). The PEG + E group took 2 L at each administration (i.e., total dose of 4 L). Bowel cleansing success was assessed via videotapes by independent, blinded raters. Statistical noninferiority was predefined as a difference of <15% in the lower limit of the 97.5% confidence interval for treatment difference. Patient views on the preparations were elicited. Adverse events were noted.

RESULTS 

Successful gut cleansing was achieved in 136 of 153 (88.9%) cases of the PEG + Asc group and 147 of 155 (94.8%) cases of the 4 L PEG + E group (mean difference –5.9 [–12.0–∞]). The difference fell within the predefined limit for noninferiority. Clinical and laboratory parameters showed no difference in safety profile. Patient ratings of acceptability and taste were better for the PEG + Asc group than for the PEG + E group (P < 0.025).

CONCLUSIONS 

The combination of ascorbic acid and PEG-based bowel preparation reduces the volume patients have to drink without compromising efficacy or safety. The low-volume PEG + Asc preparation was more acceptable to patients, and should, therefore, improve effectiveness in routine practice.

© The American College of Gastroenterology 2008. All Rights Reserved.

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Official journal of the American College of Gastroenterology | ACG103(4):883-893, April 2008.
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