Sodium Picosulfate Plus Magnesium Citrate Versus Macrogol 4000 in the Bowel Cleansing Procedure: a Comparison of Efficiency and Compatibility

This study is currently recruiting participants.
Verified November 2013 by Technische Universität München
Sponsor:
Information provided by (Responsible Party):
Technische Universität München
ClinicalTrials.gov Identifier:
NCT01607099
First received: May 24, 2012
Last updated: November 28, 2013
Last verified: November 2013

May 24, 2012
November 28, 2013
September 2012
February 2014   (final data collection date for primary outcome measure)
Valuation "very distressing" [ Time Frame: Just before colonoscopy up to 4 hours afterwards (0 to aprox 4 hours) ] [ Designated as safety issue: No ]
Patients will fill in a report in which they rate the stress triggered by the bowel cleansing procedure. The level ranges from 1 to 10 points. Valuations from 8 to 10 points will be considered as very distressing.
Valuation "very distressing" [ Time Frame: Just before colonoscopy up to 4 hours afterwards (0 to aprox 4 hours) ] [ Designated as safety issue: No ]
Patients will fill in a report in which they rate the stress initated by the bowel cleansing procedure. The level ranges from 1 to 10 points. Valuations from 8 to 10 points will be considered as very distressing.
Complete list of historical versions of study NCT01607099 on ClinicalTrials.gov Archive Site
Colon cleanness [ Time Frame: From the start to the end of colonoscopy, i.e. from 0 h to approximately 2 h ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Sodium Picosulfate Plus Magnesium Citrate Versus Macrogol 4000 in the Bowel Cleansing Procedure: a Comparison of Efficiency and Compatibility
Sodium Picosulfate Plus Magnesium Citrate Versus Macrogol 4000 in the Bowel Cleansing Procedure: a Comparison of Efficiency and Compatibility

For effective cleansing of the bowel prior to colonoscopy polyethylene glycol (e.g. macrogol) has widely been used in Germany. Usually patients have to drink between 4 an 6 liter of macrogol in a split dose (3 liter on the day before and 1 to 3 liter on the of the examination). One handicap of using polyethylene glycol is the occurence of nausea and vomiting which is due to the high amount of the laxativ and its bad taste. Therefore in a pilot study the investigators have detected a high fraction of patients who consider the cleansing procedure wich macrogol as "very distressing". Thus patient acceptance of the colonoscopy procedure altogether is low.

Since a few month sodium picosulfate/magnesium citrate is available for bowel cleansing in Germany. This preparation tastes better and needs less fluid intake. Usually 150 ml of sodium picosulfate/magnesium citrate are given twice within a 12 hour interval. Patients are instructed to drink plenty of water in addition to the laxative. In the mentioned pilot study the investigators found the cleansing procedure with picosulfate/magnesium citrate to be much more compatible compared to the macrogol regime. The effectiveness expressed by the cleanness of the bowel was equal in both groups.

The investigators believe that a new protocol which contains sodium picosulfate/magnesium citrate instead of macrogol will benefit the patients by fewer abdominal side effects while cleanness of the bowel at the same time will be warranted. This presumption is the reason for the present study.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Laxative Compatibility
Procedure: Compatibility
Patients asses the compatibility of the bowel cleansing procedure
  • Experimental: Pico Prep
    Arm in which sodium- picosulfate/magnesium citrate is used for bowel cleansing
    Intervention: Procedure: Compatibility
  • No Intervention: Standard
    The standard drug macrogol is used for bowel cleansing
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
220
March 2014
February 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age >= 18
  • Scheduled for colonoscopy

Exclusion Criteria:

  • No informed consent
  • ASA IV or V
  • Pregnancy
Both
18 Years to 90 Years
Yes
Contact: Peter Klare, MD +49 89 41405055 peter.klare@lrz.tum.de
Contact: Wolfgang Huber, MD +49 89 41402214 wolfgang.huber@lrz.tum.de
Germany
 
NCT01607099
PicoPrep
No
Technische Universität München
Technische Universität München
Not Provided
Principal Investigator: Peter Klare, MD Technische Universität München
Study Director: Wolfgang Huber, MD Technische Universität München
Technische Universität München
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP