Patient Preference With Visicol Tablet Preparation for Colonoscopy

Patient Preference and Acceptance With Sodium Phosphate Tablet Preparation for Colonoscopy: A Prospective Study

The purpose of this study is to determine patient preference and acceptance of tablet sodium phosphate bowel preparation in patients who had polyethylene glycol (PEG) solution for their prior colonoscopy. This study will provide answers related to the patient preferences and their acceptance of this new method of bowel preparation.

Study Overview

• Status: Completed
• Conditions: Preparation for Colonoscopy

• Study Type: Observational
• Enrollment (Actual): 53

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Scheduled colonoscopy list will be reviewed to identify potential subjects for recruitment. A cover letter will be sent to the potential study subject with tablet preparation as an alternative to Golytely preparation ( PEG). For subjects who are willing to participate, a prescription for 28 tablet sodium phosphate bowel preparation as outlined in appendix: A will be mailed. A questionnaire will be given to the patients prior to their colonoscopy to identify their preferences regarding bowel preparation and their acceptance ( see appendix: B).

A separate validated questionnaire will be given to participating physicians after the procedure, to quantitate the colonic cleansing (appendix : C). Adverse events will be documented. A statistical analysis of the results will be done at the end of the study.

Description

Inclusion Criteria:

• Prior colonoscopy with PEG solution in the past one year
• Must be able to swallow tablets

Exclusion Criteria:

• Patients below 18 years and above 100 years.
• Congestive heart failure
• Chronic renal failure
• Pre-existing electrolyte disorder
• Pre-existing mega-colon or a motility disorder.
• Patients with pre-existing seizure disorder.
• Patients scheduled for colonoscopy after 1:00 p.m. will be excluded from the study.
• Pregnant or lactating women

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: InKine Pharmaceutical
• Investigators: Principal Investigator: Suryakanth R. Gurudu, M.D., Mayo Clinic

Study record dates

Study Major Dates

• Study Start: March 1, 2005
• Primary Completion (Actual): April 1, 2006
• Study Completion (Actual): April 1, 2006

Study Registration Dates

• First Submitted: April 24, 2006
• First Submitted That Met QC Criteria: April 24, 2006
• First Posted (Estimate): April 26, 2006

Study Record Updates

• Last Update Posted (Estimate): December 2, 2009
• Last Update Submitted That Met QC Criteria: December 1, 2009
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Other Study ID Numbers: 392-05