NCT02062112

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
313

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

February 11, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 13, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2015

Completed
Last Updated

September 14, 2018

Status Verified

September 1, 2018

Enrollment Period

11 months

First QC Date

February 11, 2014

Last Update Submit

September 13, 2018

Conditions

ColonoscopyBowel Preparation

Keywords

Bowel preparation solutionsColonoscopyPolyethylene glycol

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    At the colonoscopy

Other Outcomes (2)

  • Prevalence of colorectal neoplasia (polyps, adenoma and cancer)

    At the colonoscopy

  • Correlation of beverage intake patterns with tolerability of bowel laxatives

    At the time of colonoscopy

Study Arms (3)

Unflavored group

NO INTERVENTION

The patient will mix 1 gallon of polyethylene glycol with water and drink as directed by his/her endoscopist. No flavoring will be added.

Flavored group

ACTIVE COMPARATOR

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

Liberal group

ACTIVE COMPARATOR

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

Interventions

Pattern of flavoring of bowel laxativeOTHER

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

Flavored groupLiberal group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Howard University

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

Location

Related Publications (1)

  • 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.

    PMID: 12811320BACKGROUND

Study Officials

  • Adeyinka O Laiyemo, MD, MPH

    Howard University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2014

First Posted

February 13, 2014

Study Start

February 11, 2014

Primary Completion

January 21, 2015

Study Completion

January 21, 2015

Last Updated

September 14, 2018

Record last verified: 2018-09

Locations

US(1)