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Completed

NCT Number: NCT02062112

Improving Tolerability of Bowel Preparation Laxative for Colonoscopy

The purpose of this study is to determine whether the pattern of flavoring and drinking of laxatives for colonoscopy can improve the experience of patients when they are undergoing bowel preparation for the test.

Investigators hypothesize that patients will have a better experience if patients taste the bowel preparation laxative with and without flavoring and then decide how they want to drink the rest of the laxative since taste preferences vary widely from person to person.

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Key information

Conditions

Colonoscopy Bowel Preparation

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Howard University

Washington D.C., District of Columbia, 20060, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults (18 years and older) referred for outpatient colonoscopy

Exclusion criteria

  • Patients with history of bowel resection
  • patients with history of inflammatory bowel disease
  • History of polyposis syndrome
  • History of colorectal cancer
  • History of poor taste perception from any cause

Treatment and study plan

Pattern of flavoring of bowel laxative

Other

Unflavored bowel laxative versus entire bowel laxative flavored versus liberal flavoring as decided by patient

Primary outcomes

  1. Overall patients' experience with the bowel preparation process with ratings from 1 (unbearable) to 10 (Pleasant)

    Time frame: At the time of colonoscopy

    On the day of the patient's colonoscopy, each patient will complete another form regarding their bowel preparation experience. Information gathered will include their ratings of the bowel preparation laxative's taste, ease of consumption, presence or absence of nausea, vomiting, whether they consumed the entire recommended laxative and their overall ratings of the bowel preparation experience.

Secondary outcomes

  1. Endoscopist ratings of the patient's bowel preparation quality using Aronchick scale

    Time frame: At the colonoscopy

    During the colonoscopy, the endoscopist who will be masked to the assignment of the patients will assess the quality of bowel preparation and grade as Poor/Inadequate, Fair, Good, Very Good or Excellent.

Other outcomes

  1. Prevalence of colorectal neoplasia (polyps, adenoma and cancer)

    Time frame: At the colonoscopy

    The detection of colorectal lesions during colonoscopy (polyps, adenoma and cancer)

  2. Correlation of beverage intake patterns with tolerability of bowel laxatives

    Time frame: At the time of colonoscopy

    Investigators will examine patients' preferred pattern of non-alcoholic beverage intake for coffee, tea and carbonated drinks with their bowel preparation experience

Sponsors and collaborators

Lead sponsor

Howard University

Other

Registry information

Official study title

Comparison of Patterns of Laxative Ingestion to Improve Bowel Preparation for Colonoscopy: A Pilot Randomized Trial

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 13, 2014
Registry last updated
Sep 14, 2018

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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