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This study will be comparing patient satisfaction, efficacy comparing miralax with gatorade versus Movi Prep for outpatient colonoscopy.
Study is the purpose of evaluating patient satisfaction and at the same time efficacy of the bowel regimen in cleansing the colon
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| miralax | Experimental | miralax with dulcolax and gatorade efficacy evaluated by colonoscopy and patient satisfaction evaluated by patient questionnaire |
|
| moviprep split dose | Experimental | Efficacy of split dose moviprep on cleansing colon for colonoscopy and patient satisfaction with the regimen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| comparing 2 drugs on their effect on the bowel preparation for colonoscopy | Drug | the effects of the drug on the colon preparation for colonoscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bowel Prep Efficacy - Boston Bowel Preparation Scale (BBPS) | To assess the bowel prep efficacy in cleansing the colon for colonoscopy - Scale used is the Boston Bowel Preparation Scale (BBPS), Integer Scale from 0-3, where 3 indicated the best outcome and 0 the worst. The BBPS was estimated during the procedure (Colonoscopy) by an endoscopist and a nurse and retrospectively by a second endoscopist postoperatively. Scores were averaged by for each subject by location (Right colon, Transverse colon, and Left colon) and then for each group/arm by location. | Outcome BBPS was measured during surgery for endoscopist #1 and nurse raters and post-operatively (at any time before the end of the study) by endoscopist #2 |
| Measure | Description | Time Frame |
|---|---|---|
| Renal Function Pre and Post Bowel Prep (mg/dL) | Changes in electrolytes pre and post bowel preparation administration. Pre bowel prep measures were taken at study randomization (up to one week before surgery) and post bowel prep measures were taken prior to the procedure (less than 5 hours before start of procedure on day of procedure). Change is electrolytes are presented as pre bowel prep value minus post bowel prep value but prior to procedure (Pre-Post). Units = Milligrams/deciLiter (mg/dL) |
| Measure | Description | Time Frame |
|---|---|---|
| Non-Serious Adverse Events on Self Report Scale | Non-Serious Adverse Events on self report scale - 5 point scale from "No Complaints (0)" to "Very Severe (4)" with 4 indicating the worst outcome and 0 the best. | During Bowel Preparation (Pre-Operative) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maqsood A Khan, MD | Rush University Medical Center | Principal Investigator |
| Ali Keshavarzian, MD | RUMC | Study Chair |
| Michael D Brown, MD | RUMC | Study Director |
| John losurdo, MD | Rush University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush Unversity Medical Center | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12135020 | Background | Rex DK, Imperiale TF, Latinovich DR, Bratcher LL. Impact of bowel preparation on efficiency and cost of colonoscopy. Am J Gastroenterol. 2002 Jul;97(7):1696-700. doi: 10.1111/j.1572-0241.2002.05827.x. | |
| 17299615 | Background | Hookey LC, Vanner S. A review of current issues underlying colon cleansing before colonoscopy. Can J Gastroenterol. 2007 Feb;21(2):105-11. doi: 10.1155/2007/634125. |
| Label | URL |
|---|---|
| rush university medical center website | View source |
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To be able to enter a recruited patient into analysis, the consented patient must complete their colonoscopy. Of the 150 consented patients, 128 completed their colonoscopy while the remaining 22 did not. Those who did not complete their colonoscopy were excluded from analysis.
A total of 150 patients were recruited and randomized to 75 patients in each arm. Of these, 128 patients arrived for the colonoscopy; therefore eligible to enter the final analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Miralax | Miralax with Dulcolax and Gatorade given orally prior to surgery |
| FG001 | Moviprep Split Dose | Split dose Moviprep given orally prior to surgery |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Miralax | Miralax with Dulcolax and Gatorade given prior to surgery. |
| BG001 | Moviprep Split Dose | Split dose Moviprep on cleansing colon given prior to surgery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of 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 | Bowel Prep Efficacy - Boston Bowel Preparation Scale (BBPS) | To assess the bowel prep efficacy in cleansing the colon for colonoscopy - Scale used is the Boston Bowel Preparation Scale (BBPS), Integer Scale from 0-3, where 3 indicated the best outcome and 0 the worst. The BBPS was estimated during the procedure (Colonoscopy) by an endoscopist and a nurse and retrospectively by a second endoscopist postoperatively. Scores were averaged by for each subject by location (Right colon, Transverse colon, and Left colon) and then for each group/arm by location. | A few of the outcomes had Missing data since the evaluations were not complete for specific locations by the clinical personnel. | Posted | Mean | Standard Deviation | score on a scale | Outcome BBPS was measured during surgery for endoscopist #1 and nurse raters and post-operatively (at any time before the end of the study) by endoscopist #2 |
|
8 Months for Adverse Events. For side effects, "Other (Not Including Serious) Adverse Events", the questionnaire for bowl prep solution was given preoperatively and collected before surgery (3 days before surgery to day of surgery).
Adverse events are reported here. Side effects were reported on a self-report scale in the outcomes section and as such the sample sizes were smaller for both groups since some subjects did not complete the questionnaire.
Of 62 in the Miralax condition 43 retuned the self-report questionnaire (19 did not) and of 66 in the Moviprep condition 51 returned the self-report questionnaire (15 did not).
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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 | Miralax | miralax with dulcolax and gatorade Condition | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment | Likert score >0 on 0-4 scale, 0 (No Complaints) to 4 (Very Severe) |
No systematic recording of incidence for non-serious adverse events were collected by study personnel or subjects, so details on event occurrence cannot be provided. Adverse events on a self-report scale of severity are recorded the table names: "Non-Serious Adverse Events on Self Report Scale" and provide an index of the perceived impact of non-serious adverse events on the subjects.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maqsood Khan MD FACG | Aurora Gastroenterology, West Allis WI | 414-328-8750 | mkhangi@yahoo.com |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D003113 | Colonoscopy |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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| Pre bowel prep measures were taken at study randomization (up to one week before surgery) and post bowel prep measures were taken prior to the procedure (less than 5 hours before start of procedure on day of procedure). |
| Renal Function Pre and Post Bowel Prep - Continued (mmol/L) | Changes in electrolytes pre and post bowel preparation administration. Pre bowel prep measures were taken at study randomization (up to one week before surgery) and post bowel prep measures were taken prior to the procedure (less than 5 hours before start of procedure on day of procedure). Change is electrolytes are presented as pre bowel prep value minus post bowel prep value, but prior to procedure (Pre-Post). Units=Millimoles per Liter (mmol/L) | Pre bowel prep measures were taken at study randomization (up to one week before surgery) and post bowel prep measures were taken prior to the procedure (less than 5 hours before start of procedure on day of procedure). |
| 14572566 | Background | DiPalma JA, Wolff BG, Meagher A, Cleveland Mv. Comparison of reduced volume versus four liters sulfate-free electrolyte lavage solutions for colonoscopy colon cleansing. Am J Gastroenterol. 2003 Oct;98(10):2187-91. doi: 10.1111/j.1572-0241.2003.07690.x. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Miralax with Dulcolax and Gatorade efficacy evaluated by colonoscopy
| OG001 | Moviprep Split Dose | Efficacy of split dose moviprep on cleansing colon for colonoscopy |
|
|
|
| Secondary | Renal Function Pre and Post Bowel Prep (mg/dL) | Changes in electrolytes pre and post bowel preparation administration. Pre bowel prep measures were taken at study randomization (up to one week before surgery) and post bowel prep measures were taken prior to the procedure (less than 5 hours before start of procedure on day of procedure). Change is electrolytes are presented as pre bowel prep value minus post bowel prep value but prior to procedure (Pre-Post). Units = Milligrams/deciLiter (mg/dL) | Posted | Mean | Standard Deviation | Milligram per deciLiter (mg/dL) | Pre bowel prep measures were taken at study randomization (up to one week before surgery) and post bowel prep measures were taken prior to the procedure (less than 5 hours before start of procedure on day of procedure). |
|
|
|
|
| Other Pre-specified | Non-Serious Adverse Events on Self Report Scale | Non-Serious Adverse Events on self report scale - 5 point scale from "No Complaints (0)" to "Very Severe (4)" with 4 indicating the worst outcome and 0 the best. | These are self-report measures and not all subject submitted or complete the self report measures. Of 62 in the Miralax condition 43 retuned the self-report questionnaire (19 did not) and of 66 in the Moviprep condition 51 returned the self-report questionnaire (15 did not). | Posted | Mean | Standard Deviation | score on a scale | During Bowel Preparation (Pre-Operative) |
|
|
|
|
| Secondary | Renal Function Pre and Post Bowel Prep - Continued (mmol/L) | Changes in electrolytes pre and post bowel preparation administration. Pre bowel prep measures were taken at study randomization (up to one week before surgery) and post bowel prep measures were taken prior to the procedure (less than 5 hours before start of procedure on day of procedure). Change is electrolytes are presented as pre bowel prep value minus post bowel prep value, but prior to procedure (Pre-Post). Units=Millimoles per Liter (mmol/L) | Posted | Mean | Standard Deviation | Millimoles per Liter (mmol/L) | Pre bowel prep measures were taken at study randomization (up to one week before surgery) and post bowel prep measures were taken prior to the procedure (less than 5 hours before start of procedure on day of procedure). |
|
|
|
| 62 |
| 0 |
| 62 |
| 22 |
| 43 |
| EG001 | Moviprep Split Dose | Split dose moviprep Condition | 0 | 66 | 0 | 66 | 28 | 51 |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment | Likert score >0 on 0-4 scale, 0 (No Complaints) to 4 (Very Severe) |
|
| Bloating | Gastrointestinal disorders | Non-systematic Assessment | Likert score >0 on 0-4 scale, 0 (No Complaints) to 4 (Very Severe) |
|
| Abdominal Pain or Cramping | Gastrointestinal disorders | Non-systematic Assessment | Likert score >0 on 0-4 scale, 0 (No Complaints) to 4 (Very Severe) |
|
| Inability to Complete Prep | Product Issues | Non-systematic Assessment | Likert score >0 on 0-4 scale, 0 (No Complaints) to 4 (Very Severe) |
|
| Difficulty in Completing Prep | Product Issues | Non-systematic Assessment | Likert score >0 on 0-4 scale, 0 (No Complaints) to 4 (Very Severe) |
|
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| Blood Urea Nitrogen |
|
| Creatinine |
|
| 0.801 |
| Mean Difference (Final Values) |
| 2.03 |
| 2-Sided |
| Superiority |
| Blood Urea Nitrogen | t-test, 2 sided | 0.599 | Mean Difference (Final Values) | -0.44 | 2-Sided | Superiority |
| Creatinine | t-test, 2 sided | 0.696 | Mean Difference (Final Values) | -0.01 | 2-Sided | Superiority |
| Sodium | t-test, 2 sided | .042 | Mean Difference (Final Values) | -1.19 | 2-Sided | Superiority |
| Potassium | t-test, 2 sided | 0.596 | Mean Difference (Final Values) | 0.07 | 2-Sided | Superiority |
| Chloride | t-test, 2 sided | 0.107 | Mean Difference (Final Values) | -0.98 | 2-Sided | Superiority |
| Bicarbonate | t-test, 2 sided | 0.351 | Mean Difference (Final Values) | 0.71 | 2-Sided | Superiority |
| Bloating |
|
| Abdominal pain or cramping |
|
| Ability to complete entire prep |
|
| Difficulty/Inconvenience in completing prep |
|
| 0.028 |
| Mean Difference (Final Values) |
| -0.2821 |
| 2-Sided |
| Superiority |
| Bloating | t-test, 2 sided | 0.235 | Mean Difference (Final Values) | -0.2102 | 2-Sided | Superiority |
| Abdominal pain or cramping | t-test, 2 sided | 0.707 | Mean Difference (Final Values) | -0.0547 | 2-Sided | Superiority |
| Ability to complete entire prep | t-test, 2 sided | 0.773 | Mean Difference (Final Values) | -0.0269 | 2-Sided | Superiority |
| Difficulty/Inconvenience in completing prep | t-test, 2 sided | 0.766 | Mean Difference (Final Values) | 0.0498 | 2-Sided | Superiority |
| Chloride |
|
| Bicarbonate |
|