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

Not Applicable

Completed

• Conditions: Laxative Compatibility
• Interventions: Procedure: Compatibility

• Registration Number: NCT01607099
• Lead Sponsor: Technical University of Munich

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-24
• Study First Submitted QC: 2012-05-25
• Study First Posted: 2012-05-28
• Study Start: 2012-09
• Primary Completion: 2014-02
• Status Verified: 2014-11
• Study Completion: 2014-11
• Last Update Submitted: 2014-11-13
• Last Update Posted: 2014-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

• Age >= 18
• Scheduled for colonoscopy

Exclusion Criteria

• No informed consent
• ASA IV or V
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pico Prep	Compatibility	Arm in which sodium- picosulfate/magnesium citrate is used for bowel cleansing

Primary Outcome Measures

Name	Time	Method
Valuation "very distressing"	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 Outcome Measures

Name	Time	Method
Colon cleanness	From the start to the end of colonoscopy, i.e. from 0 h to approximately 2 h

Trial Locations

Locations (1)

Technische Universität München; 🇩🇪 Munich, Bavaria, Germany