Small Bowel Cleansing Prior to Video Capsule Endoscopy Examination
1 other identifier
interventional
198
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2008
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 13, 2008
CompletedFirst Posted
Study publicly available on registry
May 15, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedSeptember 25, 2015
September 1, 2015
5.4 years
May 13, 2008
September 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
small bowel cleansing
during exam
Secondary Outcomes (3)
yield of Video Capsule Endoscopy (VCE) in iron deficiency
during study
tolerance of preparation
during preparation
effect of preparation on blood chemistry
24 hours after ingestion
Study Arms (3)
1
ACTIVE COMPARATORClear fluids only after lunch.
2
ACTIVE COMPARATORTwo sachets of picosalax the evening prior to Video Capsule Endoscopy (VCE).
3
ACTIVE COMPARATORPolyethylene glycol, 2 liters the evening prior to Video Capsule Endoscopy (VCE).
Interventions
Eligibility Criteria
You may qualify if:
- patients undergoing VCE.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hotel Dieu Hospital
Kingston, Ontario, Canada
Related Publications (1)
Hookey L, Louw J, Wiepjes M, Rubinger N, Van Weyenberg S, Day AG, Paterson W. Lack of benefit of active preparation compared with a clear fluid-only diet in small-bowel visualization for video capsule endoscopy: results of a randomized, blinded, controlled trial. Gastrointest Endosc. 2017 Jan;85(1):187-193. doi: 10.1016/j.gie.2016.07.028. Epub 2016 Jul 21.
PMID: 27451294DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lawrence Hookey, MD
Queen's University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
May 13, 2008
First Posted
May 15, 2008
Study Start
March 1, 2008
Primary Completion
August 1, 2013
Study Completion
June 1, 2015
Last Updated
September 25, 2015
Record last verified: 2015-09