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Completed

NCT Number: NCT01607099

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Technische Universität München

Munich, Bavaria, 81675, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >= 18
  • Scheduled for colonoscopy

Exclusion criteria

  • No informed consent
  • ASA IV or V
  • Pregnancy

Treatment and study plan

Compatibility

Procedure

Patients asses the compatibility of the bowel cleansing procedure

Primary outcomes

  1. Valuation "very distressing"

    Time frame: Just before colonoscopy up to 4 hours afterwards (0 to aprox 4 hours)

    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.

Secondary outcomes

  1. Colon cleanness

    Time frame: From the start to the end of colonoscopy, i.e. from 0 h to approximately 2 h

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
May 28, 2012
Registry last updated
Nov 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.