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

NCT00618930 | Completed Phase 4

• 1 other identifier: 2007/320
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cleansing Prior Operation

Outcome Measures

Primary Outcomes (1)

• colorectal cleansing

  prior operation

Study Arms (2)

1

EXPERIMENTAL

Drug: Moviprep®

2

ACTIVE COMPARATOR

Use of Fleet

Drug: Fleet

Interventions

Moviprep® DRUG

use of Moviprep®

1

Fleet DRUG

Use of Fleet

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Renal disease
• Heart failure
• Dehydration
• Abdominal obstruction
• Abdominal perforation
• Abdominal paralysis
• Toxic megacolon

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

• Website of the University Hospital Ghent

MeSH Terms

Interventions

MoviPrep

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 6, 2008
• First Posted: February 20, 2008
• Study Start: February 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: January 1, 2009
• Last Updated: April 15, 2009

Record last verified: 2009-04

Locations

BE (1)