We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Small Bowel Cleansing Prior to Video Capsule Endoscopy Examination

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00677794
First Posted: May 15, 2008
Last Update Posted: September 25, 2015
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.
Collaborator:
American Society for Gastrointestinal Endoscopy
Information provided by (Responsible Party):
Dr. Lawrence Hookey, Queen's University
  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
Intervention Model: Parallel Assignment
Masking: Single (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:


Further study details as provided by Dr. Lawrence Hookey, Queen's University:

Primary Outcome Measures:
  • small bowel cleansing [ Time Frame: during exam ]

Secondary Outcome Measures:
  • yield of Video Capsule Endoscopy (VCE) in iron deficiency [ Time Frame: during study ]
  • tolerance of preparation [ Time Frame: during preparation ]
  • effect of preparation on blood chemistry [ Time Frame: 24 hours after ingestion ]

Enrollment: 198
Study Start Date: March 2008
Study Completion Date: June 2015
Primary Completion Date: August 2013 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT00677794


Locations
Canada, Ontario
Hotel Dieu Hospital
Kingston, Ontario, Canada
Sponsors and Collaborators
Queen's University
American Society for Gastrointestinal Endoscopy
Investigators
Principal Investigator: Lawrence Hookey, MD Queen's University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Lawrence Hookey, Associate Professor, Queen's University
ClinicalTrials.gov Identifier: NCT00677794     History of Changes
Other Study ID Numbers: small bowel cleansing and VCE
First Submitted: May 13, 2008
First Posted: May 15, 2008
Last Update Posted: September 25, 2015
Last Verified: September 2015

Keywords provided by Dr. Lawrence Hookey, Queen's University:
Video Capsule Endoscopy
Small Bowel