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Completed

NCT Number: NCT00643682

Improving Bowel Preparation for Colonoscopy With a Simple Educational Card

The purpose of this study is to determine whether adding a simple educational card to standard pre-procedure instructions improves the quality of bowel preparation for colonoscopy.

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Key information

About this study

Despite written instructions, many patients do not understand the importance of bowel preparation as they prepare for colonoscopy. This often leads to poor compliance with preparation protocol and therefore inadequate bowel preparation. Our goal is to include a simple educational card which will hopefully improve the quality of bowel preparation by providing a visual component with the preparation instructions. This card will stress the importance of drinking the entire bowel preparation and provide representative images of a dirty and clean colon. We will specifically target patients directly booked for screening colonoscopy (those without a pre-procedure office visit). In a randomized fashion, patients in the control group will receive the standard bowel preparation instructions and patients in the intervention group will receive the educational card along with the standard bowel preparation instructions. The primary outcome will be the endoscopist's assessment of the quality of preparation using a standardized bowel preparation scale. Secondary outcomes will include the number and types of polyps found, colonoscope insertion and withdrawal time, and patient satisfaction with the procedure.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Outpatients
  • 18 years old or older
  • Referred and scheduled for an elective screening colonoscopy

Exclusion criteria

  • Inpatients
  • Prisoners
  • Cognitively impaired patients
  • Legally blind patients
  • Patients allergic to polyethylene glycol electrolyte lavage solution

Treatment and study plan

Educational card

Other

A 4x6 inch educational card containing a photo of an unprepared colon and a clean colon with the caption: "Drinking all the bowel cleaning medicine as described in the enclosed instructions lets the doctor see your colon better during your colonoscopy."

Primary outcomes

  1. Boston Bowel Preparation Scale Score

    Time frame: 2 years

    An ordinal scale. 0=fully unprepared colon and 9=perfectly clean colon. Higher values represent a better outcome. For reference please see: Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointestinal Endoscopy 2009;69:620-625. PMCID: PMC2763922

Secondary outcomes

  1. Time to Advance Colonoscope From Anus to Tip of Cecum.

    Time frame: 2 years

    time in minutes to advance colonoscope from anus to tip of cecum during insertion phase of colonoscopy.

  2. Time to Withdraw Colonoscope From Tip of Cecum to Anus.

    Time frame: 2 years

    Time in minutes to withdraw colonoscope from tip of cecum to anus during withdrawal phase of colonoscopy

  3. Number of Repeat Procedures Recommended Due to Inadequate Bowel Preparation.

    Time frame: 2 years

    The number of times a colonoscopist recommended that the bowel was too unclean to qualify as an acceptable colonoscopy and therefore recommended repeating the procedure after better cleansing. This is both the number of participants with an inadequate preparation and the number of inadequate procedures. These are synonymous.

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Mar 26, 2008
Registry last updated
Oct 1, 2012

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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