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Small Bowel Cleansing Prior to Video Capsule Endoscopy Examination

This study is currently recruiting participants.
Verified March 2012 by Queen's University
Sponsor:
Collaborator:
American Society for Gastrointestinal Endoscopy
Information provided by (Responsible Party):
Queen's University
ClinicalTrials.gov Identifier:
NCT00677794
First received: May 13, 2008
Last updated: March 6, 2012
Last verified: March 2012
History of Changes
  Purpose

There remains debate regarding whether small bowel cleansing is required prior to video capsule endoscopy, and if so, which method is best. This study prospectively tests cleansing with no preparation, preparation with picosalax, and preparation with polyethylene glycol.


Condition Intervention Phase
Endoscopy
 Drug: Clear fluids
Drug: Picosalax
Drug: Polyethylene glycol
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: Small Bowel Cleansing Prior to Video Capsule Endoscopy Examination: a Randomized, Blinded, Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Further study details as provided by Queen's University:

Primary Outcome Measures:
  • small bowel cleansing [ Time Frame: during exam ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • yield of Video Capsule Endoscopy (VCE) in iron deficiency [ Time Frame: during study ] [ Designated as safety issue: No ]
  • tolerance of preparation [ Time Frame: during preparation ] [ Designated as safety issue: No ]
  • effect of preparation on blood chemistry [ Time Frame: 24 hours after ingestion ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 180
Study Start Date: March 2008
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Clear fluids only after lunch.
 Drug: Clear fluids
Clear fluids only after lunch.
Active Comparator: 2
Two sachets of picosalax the evening prior to Video Capsule Endoscopy (VCE).
 Drug: Picosalax
Two sachets the evening prior to Video Capsule Endoscopy (VCE).
Active Comparator: 3
Polyethylene glycol, 2 liters the evening prior to Video Capsule Endoscopy (VCE).
 Drug: Polyethylene glycol
Two (2) litres the evening prior to Video Capsule Endoscopy (VCE).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients undergoing VCE.

Exclusion Criteria:

  • bowel obstruction or ileus;
  • known stricture or fistula;
  • previous small bowel surgery;
  • severe gastroparesis or motility disorder
  • renal impairment (serum creatinine over normal range within three months of study);
  • congestive heart failure;
  • cirrhosis;
  • implanted cardiac pacemaker or defibrillator or other electromedical device;
  • pregnancy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00677794

Contacts
Contact: Lawrence Hookey, MD 613-544-3400 ext 2288 hookeyl@hdh.kari.net

Locations
Canada, Ontario
Hotel Dieu Hospital Recruiting
Kingston, Ontario, Canada
Contact: Lawrence Hookey, MD     613-544-3400 ext 2288     hookeyl@hdh.kari.net    
Principal Investigator: Lawrence Hookey, MD            
Sponsors and Collaborators
Queen's University
American Society for Gastrointestinal Endoscopy
Investigators
Principal Investigator: Lawrence Hookey, MD Queen's University
  More Information

No publications provided

Responsible Party: Queen's University
ClinicalTrials.gov Identifier: NCT00677794     History of Changes
Other Study ID Numbers: small bowel cleansing and VCE
Study First Received: May 13, 2008
Last Updated: March 6, 2012
Health Authority: Canada: Health Canada

Keywords provided by Queen's University:
Video Capsule Endoscopy
Small Bowel

ClinicalTrials.gov processed this record on May 21, 2013