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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00618930
First Posted: February 20, 2008
Last Update Posted: April 15, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Ghent
  Purpose
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.

Condition Intervention Phase
Colorectal Cleansing Prior Operation Drug: Moviprep® Drug: Fleet Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Moviprep® Versus Fleet Phospho-Soda® (Golden Standard): A Study That Compared Two Laxatives on Patients Undergoing Colo-Rectal Cleansing Prior to an Abdominal Operation.

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • colorectal cleansing [ Time Frame: prior operation ]

Enrollment: 40
Study Start Date: February 2008
Study Completion Date: January 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Moviprep®
use of Moviprep®
Active Comparator: 2
Use of Fleet
Drug: Fleet
Use of Fleet

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00618930


Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
  More Information

Additional Information:
Responsible Party: Piet Pattyn, MD, PhD, University Hospital Ghent
ClinicalTrials.gov Identifier: NCT00618930     History of Changes
Other Study ID Numbers: 2007/320
First Submitted: February 6, 2008
First Posted: February 20, 2008
Last Update Posted: April 15, 2009
Last Verified: April 2009

Additional relevant MeSH terms:
Laxatives
Gastrointestinal Agents