Safety and Efficacy of High Dose Bowel Preparation Solutions for Patients With Difficult To Clean Colons For Colonoscopy
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/9/2018 |
| Start Date: | January 2016 |
| End Date: | January 2020 |
| Contact: | David P Gerard, MD |
| Email: | davidpgerard@comcast.net |
| Phone: | 630 969 1167 |
The purpose of this study is to document the safety and effectiveness of high doses of
liquids to clean the colon for colonoscopy in patients who had a previous colonoscopy with a
poorly cleaned colon.
liquids to clean the colon for colonoscopy in patients who had a previous colonoscopy with a
poorly cleaned colon.
Most of our patients use a standard dose of Gatorade (64 oz) and a tasteless laxative powder
called MiraLAX (306 g) to clean their colons out for a colonoscopy. Occasionally, patients
have chosen to use other FDA approved solutions to clean their colons including NuLYTELY,
GoLytely, MoviPrep and SuPREP. Rarely patients choose to use high doses of MagCitrate.
Despite drinking all their liquid to clean their colon, a few patients have difficult to
clean out colons and the quality of their colonoscopy preparation was not good. No one has
ever studied what liquids to give these patients when they have another colonoscopy. Most
doctors recommend using higher than standard doses of bowel cleaning liquids, but the safety
and effectiveness of these higher doses has never been studied.
Patients will already have been assigned a higher than standard dose of a bowel cleaning
liquid of their choice for their planned colonoscopy. This is our standard of care for
cleaning out the colons of patients who previous had colonoscopies with colons that were not
adequately cleaned. If the patient chooses to participate in this study, the plans to clean
their colon will remain unchanged.
Before and during the study: The subject will clean out thier colon in the days before their
colonoscopy just as they would have if they were not part of the study. They will be asked to
fill out a short questionnaire before the colonoscopy about their experience with the liquid
and the clean out process.
We would like to obtain a blood test (basic metabolic profile) that looks at each subject's
kidney function within 3 months before their colonoscopy and before the IV is started for the
colonoscopy. This involves a simple needle stick to draw 1 teaspoon (5 ml) of blood. If the
subject had had blood tests done for other reasons within 3 months of their colonoscopy,
these results can be used in place of the first blood sample.
The only research activity is the collection of patient's blood and the questionnaire the
subject will fill out before the colonoscopy. The preparation to clean their colon and the
actually colonoscopy will be unaffected by this research.
called MiraLAX (306 g) to clean their colons out for a colonoscopy. Occasionally, patients
have chosen to use other FDA approved solutions to clean their colons including NuLYTELY,
GoLytely, MoviPrep and SuPREP. Rarely patients choose to use high doses of MagCitrate.
Despite drinking all their liquid to clean their colon, a few patients have difficult to
clean out colons and the quality of their colonoscopy preparation was not good. No one has
ever studied what liquids to give these patients when they have another colonoscopy. Most
doctors recommend using higher than standard doses of bowel cleaning liquids, but the safety
and effectiveness of these higher doses has never been studied.
Patients will already have been assigned a higher than standard dose of a bowel cleaning
liquid of their choice for their planned colonoscopy. This is our standard of care for
cleaning out the colons of patients who previous had colonoscopies with colons that were not
adequately cleaned. If the patient chooses to participate in this study, the plans to clean
their colon will remain unchanged.
Before and during the study: The subject will clean out thier colon in the days before their
colonoscopy just as they would have if they were not part of the study. They will be asked to
fill out a short questionnaire before the colonoscopy about their experience with the liquid
and the clean out process.
We would like to obtain a blood test (basic metabolic profile) that looks at each subject's
kidney function within 3 months before their colonoscopy and before the IV is started for the
colonoscopy. This involves a simple needle stick to draw 1 teaspoon (5 ml) of blood. If the
subject had had blood tests done for other reasons within 3 months of their colonoscopy,
these results can be used in place of the first blood sample.
The only research activity is the collection of patient's blood and the questionnaire the
subject will fill out before the colonoscopy. The preparation to clean their colon and the
actually colonoscopy will be unaffected by this research.
Inclusion Criteria:
- Patients at least 18 years old planning to undergo an elective colonoscopy will be
eligible for inclusion in our study if they had a previous colonoscopy with an
inadequate preparation.
Exclusion Criteria:
- Patients who are pregnant.
- Patients with ileus, gastrointestinal obstruction, gastric retention, bowel
perforation, toxic colitis or toxic megacolon would not be considered elective
colonoscopies and are excluded.
We found this trial at
1
site
Downers Grove, Illinois 60515
Principal Investigator: David P Gerard, M.D.
Phone: 630-969-1167
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