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Improving Tolerability of Bowel Preparation Laxative for Colonoscopy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02062112
Enrollment
313
Registered
2014-02-13
Start date
2014-02-11
Completion date
2015-01-21
Last updated
2018-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bowel Preparation, Colonoscopy

Keywords

Bowel preparation solutions, Colonoscopy, Polyethylene glycol

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.

Interventions

OTHERPattern of flavoring of bowel laxative

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

Sponsors

Howard University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Overall patients' experience with the bowel preparation process with ratings from 1 (unbearable) to 10 (Pleasant)At the time of colonoscopyOn 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

MeasureTime frameDescription
Endoscopist ratings of the patient's bowel preparation quality using Aronchick scaleAt the colonoscopyDuring 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.

Other

MeasureTime frameDescription
Prevalence of colorectal neoplasia (polyps, adenoma and cancer)At the colonoscopyThe detection of colorectal lesions during colonoscopy (polyps, adenoma and cancer)
Correlation of beverage intake patterns with tolerability of bowel laxativesAt the time of colonoscopyInvestigators will examine patients' preferred pattern of non-alcoholic beverage intake for coffee, tea and carbonated drinks with their bowel preparation experience

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026