Moviprep® Versus Fleet Phospho-Soda® (Golden Standard): A Study That Compared Two Laxatives on Patients Undergoing Colo-Rectal Cleansing Prior to an Abdominal Operation

NCT ID: NCT00618930

Last Updated: 2009-04-15

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

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-01-31

Brief Summary

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The patients are assigned by randomisation on one of the two laxatives. After cleansing they have to fill in an evaluation form to report their findings and difficulties. Also the surgeon will be asked to fill in a score-form to report all details concerning the bowel preparation.

Detailed Description

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Conditions

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Colorectal Cleansing Prior Operation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

Group Type EXPERIMENTAL

Moviprep®

Intervention Type DRUG

use of Moviprep®

2

Use of Fleet

Group Type ACTIVE_COMPARATOR

Fleet

Intervention Type DRUG

Use of Fleet

Interventions

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Moviprep®

use of Moviprep®

Intervention Type DRUG

Fleet

Use of Fleet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Men and women
* Older than 18
* Informed consent signed
* Mode of surgery

Exclusion Criteria

* Renal disease
* Heart failure
* Dehydration
* Abdominal obstruction
* Abdominal perforation
* Abdominal paralysis
* Toxic megacolon
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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University Hospital Ghent

Locations

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University Hospital Ghent

Ghent, , Belgium

Site Status

Countries

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Belgium

Related Links

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http://www.uzgent.be

Website of the University Hospital Ghent

Other Identifiers

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2007/320

Identifier Type: -

Identifier Source: org_study_id

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