Gatorade/Miralax With or Without Bisacodyl Versus NuLytely for Colonoscopy Preparation

Condition(s) targeted: Preparation for Colonoscopy

Intervention: Gatorade/Miralax (Drug); NuLytely (Drug); Bisacodyl (Drug); Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Gastroenterology Services, Ltd.

Official(s) and/or principal investigator(s):
David P Gerard, M.D., Principal Investigator, Affiliation: Gastroenterology Services, Ltd.

Overall contact:
David P Gerard, M.D., Phone: 630 969-1167, Email: DavidPGerard@comcast.net

The purpose of this study is to compare Nulytely (or Trilyte) with a Gatorade and Miralax combination for cleaning out the colon before colonoscopy. A laxative pill called Bisacodyl may also be used with the Gatorade and Miralax to see if it helps with the clean out process. We are trying to find out if either of these methods is more acceptable to the patient and does a better job cleaning out the colon for a colonoscopy.

Official title: Gatorade/Miralax With or Without Bisacodyl vs NuLytely for Colonoscopy Preparation

Study design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: The quality of the colon preparation will be graded using the Boston Bowel Preparation Scale

Secondary outcome:

The Ottawa scale for colonoscopy preparation will be reported and compared among the 3 groups to allow for comparisons to some of the older literature

We will compare how well each preparation is tolerated using a patient question questionnaire

We will compare how well each preparation was tolerated by checking a basic metabolic profile before the IV is started for the colonoscopy

We will compare the quality of each preparation by asking the doctor "Did you consider the preparation adequate for a good quality colonoscopy?"

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. Patients at least 18 years old planning to undergo an elective colonoscopy.

Exclusion Criteria:

1. Patients who are allergic or intolerant to any on the study drugs.

2. Pregnant patients.

3. Patients who required multiple day colon preparation in the past.

4. Patients with ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or toxic megacolon would not be considered elective colonoscopies and are excluded.

David P Gerard, M.D., Phone: 630 969-1167, Email: DavidPGerard@comcast.net

Gastroenterology Services, Downers Grove, Illinois 60515, United States; Recruiting
David P Gerard, M.D., Phone: 630-969-1167, Email: DavidPGerard@comcast.net
Diane Foster, P.A.-c, Phone: 630 969-1167, Email: GIServices@comcast.net
David P Gerard, M.D., Principal Investigator
Manfred W Raiser, M.D., Sub-Investigator
John L Holden, M.D., Sub-Investigator
Diane Foster, P.A.-c, Sub-Investigator

Starting date: February 2010
Last updated: February 4, 2010