Small Bowel Cleansing Prior to Video Capsule Endoscopy Examination

This study is currently recruiting participants.

Verified by Queen's University, December 2008

First Received: May 13, 2008 Last Updated: December 8, 2008 History of Changes

Sponsors and Collaborators:	Queen's University American Society for Gastrointestinal Endoscopy
Information provided by:	Queen's University
ClinicalTrials.gov Identifier:	NCT00677794

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 IV

MedlinePlus related topics: Endoscopy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Small Bowel Cleansing Prior to Video Capsule Endoscopy Examination: a Randomized, Blinded, Controlled Trial

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:	September 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Clear fluids only after lunch.	Drug: Clear fluids Clear fluids only after lunch.
2: Active Comparator Two sachets of picosalax the evening prior to Video Capsule Endoscopy (VCE).	Drug: Picosalax Two sachets the evening prior to Video Capsule Endoscopy (VCE).
3: Active Comparator 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 ( Dr. Lawrence Hookey )
Study ID Numbers:	small bowel cleansing and VCE
Study First Received:	May 13, 2008
Last Updated:	December 8, 2008
ClinicalTrials.gov Identifier:	NCT00677794 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Queen's University:

Video Capsule Endoscopy
Small Bowel

ClinicalTrials.gov processed this record on May 07, 2009