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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01607099
Enrollment
220
Registered
2012-05-28
Start date
2012-09-30
Completion date
2014-11-30
Last updated
2014-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laxative Compatibility

Keywords

colonoscopy, bowel cleansing, bowel cleanness, efficiency, compatibility

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.

Interventions

PROCEDURECompatibility

Patients asses the compatibility of the bowel cleansing procedure

Sponsors

Technical University of Munich
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

Inclusion criteria

* Age \>= 18 * Scheduled for colonoscopy

Exclusion criteria

* No informed consent * ASA IV or V * Pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Valuation very distressingJust 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

MeasureTime frame
Colon cleannessFrom the start to the end of colonoscopy, i.e. from 0 h to approximately 2 h

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026