Improving Tolerability of Bowel Preparation Laxative for Colonoscopy

Not Applicable

Completed

• Conditions: Bowel Preparation; Colonoscopy
• Interventions: Other: Pattern of flavoring of bowel laxative

• Registration Number: NCT02062112
• Lead Sponsor: Howard University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-11
• Study First Submitted: 2014-02-11
• Study First Submitted QC: 2014-02-11
• Study First Posted: 2014-02-13
• Primary Completion: 2015-01-21
• Study Completion: 2015-01-21
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-13
• Last Update Posted: 2018-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 313

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liberal group	Pattern of flavoring of bowel laxative	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.
Flavored group	Pattern of flavoring of bowel laxative	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.

Primary Outcome Measures

Name	Time	Method
Overall patients' experience with the bowel preparation process with ratings from 1 (unbearable) to 10 (Pleasant)	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 Outcome Measures

Name	Time	Method
Endoscopist ratings of the patient's bowel preparation quality using Aronchick scale	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.

Trial Locations

Locations (1)

Howard University; 🇺🇸 Washington, District of Columbia, United States