Small Bowel Cleansing Prior to Video Capsule Endoscopy Examination

Endoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00677794
• Other study ID #: small bowel cleansing and VCE
• Status: Completed
• Phase: Phase 4
• First received: May 13, 2008
• Last updated: September 23, 2015
• Start date: March 2008
• Est. completion date: June 2015

Study information

• Verified date: September 2015
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: June 2015
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Endoscopy

Intervention

Drug:
• Clear fluids
Clear fluids only after lunch.
• Picosalax
Two sachets the evening prior to Video Capsule Endoscopy (VCE).
• Polyethylene glycol
Two (2) litres the evening prior to Video Capsule Endoscopy (VCE).

Locations

Country	Name	City	State
Canada	Hotel Dieu Hospital	Kingston	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Queen's University	American Society for Gastrointestinal Endoscopy

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	small bowel cleansing		during exam	No
Secondary	yield of Video Capsule Endoscopy (VCE) in iron deficiency		during study	No
Secondary	tolerance of preparation		during preparation	No
Secondary	effect of preparation on blood chemistry		24 hours after ingestion	Yes