NCT00318305

Brief Summary

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status
completed
Actual enrollment (reported)
53 participants
Study completion date

April 2006

Actual (reported)
Listed locations
1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

  1. Study Start

    March 2005

    Date type not reported

    This date has not been verified as actual or estimated.

  2. Primary Completion

    April 2006

    Actual (reported)

  3. Study Completion

    April 2006

    Actual (reported)

  4. First Submitted

    April 24, 2006

    Actual (reported)

  5. First Posted

    April 26, 2006

    Actual (reported)
Last Updated
December 2, 2009
Status Verified
December 2009
Last Update Submitted
December 1, 2009

Conditions

Preparation for Colonoscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

Study Officials

  • Suryakanth R. Gurudu, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Enrollment

53 participants — actual enrollment reported by the registry.

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 24, 2006

First Posted

April 26, 2006

Study Start

March 2005

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

April 2006

Actual (reported)

Study Completion

April 2006

Actual (reported)

Last Updated

December 2, 2009

Record last verified: 2009-12

Locations

US(1)