Improving Tolerability of Bowel Preparation Laxative for Colonoscopy

Overview

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.

Full Title of Study: “Comparison of Patterns of Laxative Ingestion to Improve Bowel Preparation for Colonoscopy: A Pilot Randomized Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: January 21, 2015

Interventions

  • Other: Pattern of flavoring of bowel laxative
    • Unflavored bowel laxative versus entire bowel laxative flavored versus liberal flavoring as decided by patient

Arms, Groups and Cohorts

  • No Intervention: Unflavored group
    • The patient will mix 1 gallon of polyethylene glycol with water and drink as directed by his/her endoscopist. No flavoring will be added.
  • Active Comparator: Flavored group
    • The patient will mix 1 gallon of polyethylene glycol with water, add flavoring to the entire solution and drink at the time specified by his/her endoscopist.
  • Active Comparator: Liberal group
    • The patient will mix 1 gallon of polyethylene glycol with water. Fill 2 cups with the solution. The patient will add flavoring to one cup and drink both the flavored and unflavored solutions in the cups. The patient will then determine how he/she wants to drink the rest of the bowel preparation laxatives based on their taste preference and drink at the time specified by his/her endoscopist.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Howard University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Adeyinka O Laiyemo, MD, MPH, Principal Investigator, Howard University

References

Hayes A, Buffum M, Fuller D. Bowel preparation comparison: flavored versus unflavored colyte. Gastroenterol Nurs. 2003 May-Jun;26(3):106-9. doi: 10.1097/00001610-200305000-00004.

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