Small Bowel Cleansing Prior to Video Capsule Endoscopy Examination

Small Bowel Cleansing Prior to Video Capsule Endoscopy Examination: a Randomized, Blinded, Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Endoscopy
• Intervention / Treatment: Drug: Clear fluids; Drug: Picosalax; Drug: Polyethylene glycol

• Study Type: Interventional
• Enrollment (Actual): 198
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada
      • Hotel Dieu Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
small bowel cleansing	during exam

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Queen's University
• Collaborators: American Society for Gastrointestinal Endoscopy

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: May 13, 2008
• First Submitted That Met QC Criteria: May 14, 2008
• First Posted (Estimate): May 15, 2008

Study Record Updates

• Last Update Posted (Estimate): September 25, 2015
• Last Update Submitted That Met QC Criteria: September 23, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Small Bowel; Video Capsule Endoscopy
• Other Study ID Numbers: small bowel cleansing and VCE