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:
Information provided by:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00618930
First received: February 6, 2008
Last updated: April 14, 2009
Last verified: April 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00618930

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

Additional Information:
No publications provided

Responsible Party: Piet Pattyn, MD, PhD, University Hospital Ghent
ClinicalTrials.gov Identifier: NCT00618930     History of Changes
Other Study ID Numbers: 2007/320
Study First Received: February 6, 2008
Last Updated: April 14, 2009
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Laxatives
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014