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Optimal Bowel Cleansing Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01624454
First Posted: June 20, 2012
Last Update Posted: May 9, 2013
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 (Responsible Party):
Helse Stavanger HF
  Purpose
Comparison between large volume and osmotic agent lavage for optimal colonoscopy bowel cleansing, randomizing adult outpatients by invitation letter

Condition Intervention
Bowel Cleansing for Colonoscopy Other: Laxabon Other: CitraFleet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Osmotic or Large Volume Lavage for Optimal Bowel Preparation - a Single-blind Randomized Trial

Resource links provided by NLM:


Further study details as provided by Helse Stavanger HF:

Primary Outcome Measures:
  • Bowel cleansing quality [ Time Frame: 1 Day ]

Secondary Outcome Measures:
  • Colonoscopy findings [ Time Frame: 1 Day ]

Enrollment: 380
Study Start Date: April 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: large volume
bowel cleansing with PEG
Other: Laxabon
4 l PEG solution split dose cleansing
Active Comparator: Osmotic Other: CitraFleet
Small volume osmotic bowelcleansing

Detailed Description:

This randomized quality assurance trial aims to compare cleansing quality of two different principles of colonoscopy lavage. Large volume PEG solutions are considered safe, but cumbersome and inpalatable, while osmotic solutions are generally more acceptable, however, the risk of electrolyte disturbances or renal decompensation may increase.

The study will focus on patient experience and compliance, as well as cleansing quality, endoscopic findings and other technical parameters of the colonoscopy procedure that may be adversely affected by poor bowel cleansing. Three centers will participate, ensuring a diverse patient population. 800 patients are planned for recruitment, but an interim assessment of statistics of the primary aim parameter (bowel cleansing) will be performed to adjust the number.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pts for out-patient colonoscopy
  • age 18-80

Exclusion Criteria:

  • Active colitis or suspicion thereof (bloody diarrhea, fever and abdominal pain)
  • Suspicion of renal insufficiency or ileus/subileus
  • Previous colonic surgery
  • Pregnancy
  • Inability to adhere to cleansing instructions
  • Inability to consent
  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): NCT01624454


Locations
Norway
Sørlandet sykehus
Kristiansand, VestAgder, Norway
OUS Rikshospitalet, dept of med gastro
Oslo, Norway
Sponsors and Collaborators
Helse Stavanger HF
Investigators
Principal Investigator: Lars Aabakken, prof of med Prof of medicine
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT01624454     History of Changes
Other Study ID Numbers: SUS-CRAP
First Submitted: June 18, 2012
First Posted: June 20, 2012
Last Update Posted: May 9, 2013
Last Verified: June 2012

Keywords provided by Helse Stavanger HF:
colonoscopy
bowel cleansing