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OpenTrials
Completed

NCT Number: NCT00677794

Small Bowel Cleansing Prior to Video Capsule Endoscopy Examination

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.

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Key information

Conditions

Endoscopy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hotel Dieu Hospital

Kingston, Ontario, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clear fluids

Drug

Clear fluids only after lunch.

Picosalax

Drug

Two sachets the evening prior to Video Capsule Endoscopy (VCE).

Polyethylene glycol

Drug

Two (2) litres the evening prior to Video Capsule Endoscopy (VCE).

Primary outcomes

  1. small bowel cleansing

    Time frame: during exam

Secondary outcomes

  1. yield of Video Capsule Endoscopy (VCE) in iron deficiency

    Time frame: during study

  2. tolerance of preparation

    Time frame: during preparation

  3. effect of preparation on blood chemistry

    Time frame: 24 hours after ingestion

Sponsors and collaborators

Lead sponsor

Queen's University

Other

Collaborators

  • American Society for Gastrointestinal Endoscopy

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2013
Study completion
2015
First posted
May 15, 2008
Registry last updated
Sep 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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