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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
|Official Title:||Sodium Picosulfate Plus Magnesium Citrate Versus Macrogol 4000 in the Bowel Cleansing Procedure: a Comparison of Efficiency and Compatibility|
- 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.
- 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 ]
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||March 2014|
|Estimated Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
Experimental: Pico Prep
Arm in which sodium- picosulfate/magnesium citrate is used for bowel cleansing
Patients asses the compatibility of the bowel cleansing procedure
No Intervention: Standard
The standard drug macrogol is used for bowel cleansing
Please refer to this study by its ClinicalTrials.gov identifier: NCT01607099
|Contact: Peter Klare, MD||+49 89 email@example.com|
|Contact: Wolfgang Huber, MD||+49 89 firstname.lastname@example.org|
|Technische Universität München||Recruiting|
|Munich, Bavaria, Germany, 81675|
|Principal Investigator:||Peter Klare, MD||Technische Universität München|
|Study Director:||Wolfgang Huber, MD||Technische Universität München|