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

NCT ID: NCT01607099

Last Updated: 2014-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-11-30

Brief Summary

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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

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Conditions

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Laxative Compatibility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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Pico Prep

Arm in which sodium- picosulfate/magnesium citrate is used for bowel cleansing

Group Type EXPERIMENTAL

Compatibility

Intervention Type PROCEDURE

Patients asses the compatibility of the bowel cleansing procedure

Standard

The standard drug macrogol is used for bowel cleansing

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Compatibility

Patients asses the compatibility of the bowel cleansing procedure

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age \>= 18
* Scheduled for colonoscopy

Exclusion Criteria

* No informed consent
* ASA IV or V
* Pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Klare, MD

Role: PRINCIPAL_INVESTIGATOR

Technical University of Munich

Wolfgang Huber, MD

Role: STUDY_DIRECTOR

Technical University of Munich

Locations

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Technische Universität München

Munich, Bavaria, Germany

Site Status

Countries

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Germany

Other Identifiers

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PicoPrep

Identifier Type: -

Identifier Source: org_study_id