Improving Tolerability of Bowel Preparation Laxative for Colonoscopy

Colonoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02062112
• Other study ID #: IRB-13-MED-60
• Status: Completed
• Phase: N/A
• Start date: February 11, 2014
• Est. completion date: January 21, 2015

Study information

• Verified date: September 2018
• Source: Howard University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 313
• Est. completion date: January 21, 2015
• Est. primary completion date: January 21, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Bowel Preparation
• Colonoscopy

Intervention

Other:
• Pattern of flavoring of bowel laxative
Unflavored bowel laxative versus entire bowel laxative flavored versus liberal flavoring as decided by patient

Locations

Country	Name	City	State
United States	Howard University	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Howard University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Hayes A, Buffum M, Fuller D. Bowel preparation comparison: flavored versus unflavored colyte. Gastroenterol Nurs. 2003 May-Jun;26(3):106-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Prevalence of colorectal neoplasia (polyps, adenoma and cancer)	The detection of colorectal lesions during colonoscopy (polyps, adenoma and cancer)	At the colonoscopy
Other	Correlation of beverage intake patterns with tolerability of bowel laxatives	Investigators will examine patients' preferred pattern of non-alcoholic beverage intake for coffee, tea and carbonated drinks with their bowel preparation experience	At the time of colonoscopy
Primary	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	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