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

April 14, 2009 updated by: University Hospital, Ghent

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • University Hospital Ghent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Moviprep®
use of Moviprep®
Active Comparator: 2
Use of Fleet
Drug: Fleet
Use of Fleet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
colorectal cleansing
Time Frame: prior operation
prior operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

February 6, 2008

First Submitted That Met QC Criteria

February 19, 2008

First Posted (Estimate)

February 20, 2008

Study Record Updates

Last Update Posted (Estimate)

April 15, 2009

Last Update Submitted That Met QC Criteria

April 14, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Other Study ID Numbers

  • 2007/320

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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