Optimal Bowel Cleansing Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Helse Stavanger HF
ClinicalTrials.gov Identifier:
NCT01624454
First received: June 18, 2012
Last updated: May 7, 2013
Last verified: June 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Colonoscopy findings [ Time Frame: 1 Day ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT01624454     History of Changes
Other Study ID Numbers: SUS-CRAP
Study First Received: June 18, 2012
Last Updated: May 7, 2013
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by Helse Stavanger HF:
colonoscopy
bowel cleansing

ClinicalTrials.gov processed this record on July 29, 2014