NCT01607099|Completed
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Sponsor study identifier
interventional
220
1 country
1
Study Start
September 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2014
Actual (reported)Study Completion
November 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2014
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 24, 2012
Actual (reported)May 28, 2012
Actual (reported)September 2012
Date type not reportedThis date has not been verified as actual or estimated.
February 2014
Actual (reported)November 2014
Actual (reported)Valuation "very distressing"
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.
Just before colonoscopy up to 4 hours afterwards (0 to aprox 4 hours)
Colon cleanness
From the start to the end of colonoscopy, i.e. from 0 h to approximately 2 h
Arm in which sodium- picosulfate/magnesium citrate is used for bowel cleansing
The standard drug macrogol is used for bowel cleansing
Patients asses the compatibility of the bowel cleansing procedure
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Technische Universität München
Munich, Bavaria, 81675, Germany
Peter Klare, MD
Technical University of Munich
Wolfgang Huber, MD
Technical University of Munich
220 participants (actual enrollment reported by the registry).
First Submitted
May 24, 2012
First Posted
May 28, 2012
Study Start
September 2012
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
February 2014
Actual (reported)Study Completion
November 2014
Actual (reported)Last Updated
November 14, 2014
Record last verified: 2014-11
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Source: ClinicalTrials.gov.
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