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Poor bowel preparation and patient intolerance of the procedure are the most important factors contributing to the limitation of colonoscopy. Inadequate bowel cleansing results in incomplete testing, increased potential to miss lesions, increased cost, and decreased patient satisfaction. The investigators hope to gain better insight into which bowel preparation works best in diabetic patients and hence would increase patient satisfaction, tolerability of the bowel preparation and decrease overall costs. The investigators will investigate which bowel preparation for colonoscopy will work optimally in diabetic patients using three different regimens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Golytely + placebo | Active Comparator | 4 liters of polyethylene glycol electrolyte lavage solution (PEG-ELS-(GoLytely)+ placebo pill |
|
| Golytely Split + placebo | Placebo Comparator | split dose(2 L day before procedure and 2 L day of procedure) of 4 liters of Golytely + placebo pill |
|
| Golytely Split + Bisacodyl | Experimental | split dose (2 L day prior to procedure and 2 L day of procedure) of 4 liters of Golytely + bisacodyl 10 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Golytely (polyethylene glycol electrolyte lavage solution) and placebo | Drug | 4 liters of polyethylene glycol electrolyte lavage solution (PEG-ELS-(GoLytely))+ placebo given the evening prior to the colonoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| Measure the % of Participants With Effective (How Well the Colon is Cleansed Using the Validated Boston Bowel Preparation Scale) for Various Bowel Preparations for Colonoscopy. | The investigators will measure the number/% of participants who will have good to excellent bowel preparations defined by the Boston Bowel Prep Scale(BBPS) with a score of 6 or more, rated by blinded colonoscopist. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Measure of Patients Who Develop (Tolerance)Side Effects of Taking Bowel Preparations. | Number of Participants Who Developed Side Effects of Taking Bowel Preparations | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohammad Madhoun, MD | University of Oklahoma Health Science Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oklahoma VA Medical Center | Oklahoma City | Oklahoma | 73104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Golytely + Placebo | 4 liters of polyethylene glycol electrolyte lavage solution (PEG-ELS-(GoLytely)+ placebo pill Golytely (polyethylene glycol electrolyte lavage solution) and placebo: 4 liters of polyethylene glycol electrolyte lavage solution (PEG-ELS-(GoLytely))+ placebo given the evening prior to the colonoscopy |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| split dose of Golytely (polyethylene glycol electrolyte lavage solution) + placebo | Drug | split dose (2 L taken the evening before and 2 L taken the morning of the colonoscopy) of 4 liters Golytely + placebo |
|
| split dose of Golytely (polyethylene glycol electrolyte lavage solution) and bisacodyl | Drug | split dose ( 2 L taken the evening before and 2 L taken the morning of the colonoscopy) of 4 liters of Golytely + bisacodyl 10 mg |
|
| Golytely Split + Placebo |
split dose(2 L day before procedure and 2 L day of procedure) of 4 liters of Golytely + placebo pill split dose of Golytely (polyethylene glycol electrolyte lavage solution) + placebo: split dose (2 L taken the evening before and 2 L taken the morning of the colonoscopy) of 4 liters Golytely + placebo |
| FG002 | Golytely Split + Bisacodyl | split dose (2 L day prior to procedure and 2 L day of procedure) of 4 liters of Golytely + bisacodyl 10 mg split dose of Golytely (polyethylene glycol electrolyte lavage solution) and bisacodyl: split dose ( 2 L taken the evening before and 2 L taken the morning of the colonoscopy) of 4 liters of Golytely + bisacodyl 10 mg |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Golytely + Placebo | 4 liters of polyethylene glycol electrolyte lavage solution (PEG-ELS-(GoLytely)+ placebo pill Golytely (polyethylene glycol electrolyte lavage solution) and placebo: 4 liters of polyethylene glycol electrolyte lavage solution (PEG-ELS-(GoLytely))+ placebo given the evening prior to the colonoscopy |
| BG001 | Golytely Split + Placebo | split dose(2 L day before procedure and 2 L day of procedure) of 4 liters of Golytely + placebo pill split dose of Golytely (polyethylene glycol electrolyte lavage solution) + placebo: split dose (2 L taken the evening before and 2 L taken the morning of the colonoscopy) of 4 liters Golytely + placebo |
| BG002 | Golytely Split + Bisacodyl | split dose (2 L day prior to procedure and 2 L day of procedure) of 4 liters of Golytely + bisacodyl 10 mg split dose of Golytely (polyethylene glycol electrolyte lavage solution) and bisacodyl: split dose ( 2 L taken the evening before and 2 L taken the morning of the colonoscopy) of 4 liters of Golytely + bisacodyl 10 mg |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Measure the % of Participants With Effective (How Well the Colon is Cleansed Using the Validated Boston Bowel Preparation Scale) for Various Bowel Preparations for Colonoscopy. | The investigators will measure the number/% of participants who will have good to excellent bowel preparations defined by the Boston Bowel Prep Scale(BBPS) with a score of 6 or more, rated by blinded colonoscopist. | We have missing data regarding reporting of Boston bowel preparation scores (BBPS), some providers didn't provide the BBPS and provided only subjective assessment of the bowel preparation (for example, good or excellent) | Posted | Count of Participants | Participants | Day 1 |
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| Secondary | Measure of Patients Who Develop (Tolerance)Side Effects of Taking Bowel Preparations. | Number of Participants Who Developed Side Effects of Taking Bowel Preparations | Posted | Count of Participants | Participants | 24 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Golytely + Placebo | 4 liters of polyethylene glycol electrolyte lavage solution (PEG-ELS-(GoLytely)+ placebo pill Golytely (polyethylene glycol electrolyte lavage solution) and placebo: 4 liters of polyethylene glycol electrolyte lavage solution (PEG-ELS-(GoLytely))+ placebo given the evening prior to the colonoscopy | 0 | 63 | 24 | 63 | ||
| EG001 | Golytely Split + Placebo | split dose(2 L day before procedure and 2 L day of procedure) of 4 liters of Golytely + placebo pill split dose of Golytely (polyethylene glycol electrolyte lavage solution) + placebo: split dose (2 L taken the evening before and 2 L taken the morning of the colonoscopy) of 4 liters Golytely + placebo | 0 | 60 | 27 | 60 | ||
| EG002 | Golytely Split + Bisacodyl | split dose (2 L day prior to procedure and 2 L day of procedure) of 4 liters of Golytely + bisacodyl 10 mg split dose of Golytely (polyethylene glycol electrolyte lavage solution) and bisacodyl: split dose ( 2 L taken the evening before and 2 L taken the morning of the colonoscopy) of 4 liters of Golytely + bisacodyl 10 mg | 0 | 63 | 28 | 63 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea and vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Bloating | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Rectal burning sensation | Gastrointestinal disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mohammad Madhoun | UOklahoma | 405-456-326- | mohammad-madhoun@ouhsc.edu |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C033608 | Golytely |
| D001726 | Bisacodyl |
| ID | Term |
|---|---|
| D003408 | Cresols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Male |
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| Other |
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