Improving Tolerability of Bowel Preparation Laxative for Colonoscopy

Study Overview
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Brief Summary
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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.

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

Conditions
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Colonoscopy, Bowel Preparation

Intervention / Treatment
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* Other: Pattern of flavoring of bowel laxative


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Unflavored group<br>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<br>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. | Other: Pattern of flavoring of bowel laxative<br>* Unflavored bowel laxative versus entire bowel laxative flavored versus liberal flavoring as decided by patient<br>|
| Active Comparator: Liberal group<br>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. | Other: Pattern of flavoring of bowel laxative<br>* Unflavored bowel laxative versus entire bowel laxative flavored versus liberal flavoring as decided by patient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall patients' experience with the bowel preparation process with ratings from 1 (unbearable) to 10 (Pleasant) | 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. | At the time of colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoscopist ratings of the patient's bowel preparation quality using Aronchick scale | 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. | At the colonoscopy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bowel preparation solutions, Colonoscopy, Polyethylene glycol