Improving Tolerability of Bowel Preparation Laxative for Colonoscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

313 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-11

Study Completion Date

2015-01-21

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.

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Detailed Description

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Conditions

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Colonoscopy Bowel Preparation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

Pattern of flavoring of bowel laxative

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

Pattern of flavoring of bowel laxative

Intervention Type OTHER

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

Interventions

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Pattern of flavoring of bowel laxative

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

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No