Colorectal Cancer
Conditions
Keywords
Miralax with gatorade and dulcolax, Movi pre, Patient satisfaction and efficacy
Brief summary
This study will be comparing patient satisfaction, efficacy comparing miralax with gatorade versus Movi Prep for outpatient colonoscopy.
Detailed description
Study is the purpose of evaluating patient satisfaction and at the same time efficacy of the bowel regimen in cleansing the colon
Interventions
DRUGcomparing 2 drugs on their effect on the bowel preparation for colonoscopy
the effects of the drug on the colon preparation for colonoscopy
Sponsors
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* outpatient colonoscopy for screening for other Gi related problems
Exclusion criteria
* Severe Congestive Heart Failure (CHF), * Chronic Kidney Disease (CKD), * less than age 18 or more than 80 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bowel Prep Efficacy - Boston Bowel Preparation Scale (BBPS) | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Renal Function Pre and Post Bowel Prep (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). | 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) |
| Renal Function Pre and Post Bowel Prep - Continued (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). | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Non-Serious Adverse Events on Self Report Scale | During Bowel Preparation (Pre-Operative) | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Miralax Miralax with Dulcolax and Gatorade given prior to surgery. | 62 |
| Moviprep Split Dose Split dose Moviprep on cleansing colon given prior to surgery | 66 |
| Total | 128 |
Baseline characteristics
| Characteristic | Moviprep Split Dose | Total | Miralax |
|---|---|---|---|
| Age, Customized Age > 18 Years | 66 Participants | 128 Participants | 62 Participants |
| Sex: Female, Male Female | 37 Participants | 73 Participants | 36 Participants |
| Sex: Female, Male Male | 29 Participants | 55 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 62 | 0 / 66 |
| other Total, other adverse events | 22 / 43 | 28 / 51 |
| serious Total, serious adverse events | 0 / 62 | 0 / 66 |
Outcome results
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.
Time frame: 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
Population: A few of the outcomes had Missing data since the evaluations were not complete for specific locations by the clinical personnel.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Miralax | Bowel Prep Efficacy - Boston Bowel Preparation Scale (BBPS) | Left Colon | 2.24 score on a scale | Standard Deviation 0.76 |
| Miralax | Bowel Prep Efficacy - Boston Bowel Preparation Scale (BBPS) | Right Colon | 1.79 score on a scale | Standard Deviation 0.72 |
| Miralax | Bowel Prep Efficacy - Boston Bowel Preparation Scale (BBPS) | Transverse Colon | 2.06 score on a scale | Standard Deviation 0.79 |
| Moviprep Split Dose | Bowel Prep Efficacy - Boston Bowel Preparation Scale (BBPS) | Right Colon | 2.33 score on a scale | Standard Deviation 0.89 |
| Moviprep Split Dose | Bowel Prep Efficacy - Boston Bowel Preparation Scale (BBPS) | Transverse Colon | 2.45 score on a scale | Standard Deviation 0.72 |
| Moviprep Split Dose | Bowel Prep Efficacy - Boston Bowel Preparation Scale (BBPS) | Left Colon | 2.46 score on a scale | Standard Deviation 0.7 |
Comparison: Right Colonp-value: <0.000195% CI: [0.269, 0.816]t-test, 2 sided
Comparison: Transverse Colonp-value: 0.00595% CI: [0.122, 0.655]t-test, 2 sided
Comparison: Left Colonp-value: 0.0895% CI: [-0.029, 0.484]t-test, 2 sided
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)
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Miralax | Renal Function Pre and Post Bowel Prep - Continued (mmol/L) | Sodium | 0.27 Millimoles per Liter (mmol/L) | Standard Deviation 3.28 |
| Miralax | Renal Function Pre and Post Bowel Prep - Continued (mmol/L) | Potassium | -0.18 Millimoles per Liter (mmol/L) | Standard Deviation 0.74 |
| Miralax | Renal Function Pre and Post Bowel Prep - Continued (mmol/L) | Chloride | 0.54 Millimoles per Liter (mmol/L) | Standard Deviation 3.41 |
| Miralax | Renal Function Pre and Post Bowel Prep - Continued (mmol/L) | Bicarbonate | 1.43 Millimoles per Liter (mmol/L) | Standard Deviation 4.29 |
| Moviprep Split Dose | Renal Function Pre and Post Bowel Prep - Continued (mmol/L) | Bicarbonate | 2.14 Millimoles per Liter (mmol/L) | Standard Deviation 4.29 |
| Moviprep Split Dose | Renal Function Pre and Post Bowel Prep - Continued (mmol/L) | Sodium | -0.92 Millimoles per Liter (mmol/L) | Standard Deviation 3.28 |
| Moviprep Split Dose | Renal Function Pre and Post Bowel Prep - Continued (mmol/L) | Chloride | -0.44 Millimoles per Liter (mmol/L) | Standard Deviation 3.41 |
| Moviprep Split Dose | Renal Function Pre and Post Bowel Prep - Continued (mmol/L) | Potassium | -0.11 Millimoles per Liter (mmol/L) | Standard Deviation 0.74 |
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)
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Miralax | Renal Function Pre and Post Bowel Prep (mg/dL) | Calcium | 0.18 Milligram per deciLiter (mg/dL) | Standard Deviation 0.53 |
| Miralax | Renal Function Pre and Post Bowel Prep (mg/dL) | Glucose | 1.41 Milligram per deciLiter (mg/dL) | Standard Deviation 45.44 |
| Miralax | Renal Function Pre and Post Bowel Prep (mg/dL) | Blood Urea Nitrogen | 3.44 Milligram per deciLiter (mg/dL) | Standard Deviation 4.72 |
| Miralax | Renal Function Pre and Post Bowel Prep (mg/dL) | Creatinine | -0.01 Milligram per deciLiter (mg/dL) | Standard Deviation 0.14 |
| Moviprep Split Dose | Renal Function Pre and Post Bowel Prep (mg/dL) | Creatinine | -0.02 Milligram per deciLiter (mg/dL) | Standard Deviation 0.14 |
| Moviprep Split Dose | Renal Function Pre and Post Bowel Prep (mg/dL) | Calcium | 0.02 Milligram per deciLiter (mg/dL) | Standard Deviation 0.53 |
| Moviprep Split Dose | Renal Function Pre and Post Bowel Prep (mg/dL) | Blood Urea Nitrogen | 3.00 Milligram per deciLiter (mg/dL) | Standard Deviation 4.72 |
| Moviprep Split Dose | Renal Function Pre and Post Bowel Prep (mg/dL) | Glucose | 3.44 Milligram per deciLiter (mg/dL) | Standard Deviation 45.44 |
Comparison: Creatininep-value: 0.696t-test, 2 sided
Comparison: Calciump-value: 0.093t-test, 2 sided
Comparison: Glucosep-value: 0.801t-test, 2 sided
Comparison: Blood Urea Nitrogenp-value: 0.599t-test, 2 sided
Comparison: Sodiump-value: 0.042t-test, 2 sided
Comparison: Potassiump-value: 0.596t-test, 2 sided
Comparison: Chloridep-value: 0.107t-test, 2 sided
Comparison: Bicarbonatep-value: 0.351t-test, 2 sided
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.
Time frame: During Bowel Preparation (Pre-Operative)
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Miralax | Non-Serious Adverse Events on Self Report Scale | Nausea | 0.3590 score on a scale | Standard Deviation 0.77 |
| Miralax | Non-Serious Adverse Events on Self Report Scale | Vomiting | 0.2821 score on a scale | Standard Deviation 0.85 |
| Miralax | Non-Serious Adverse Events on Self Report Scale | Bloating | 0.6667 score on a scale | Standard Deviation 0.89 |
| Miralax | Non-Serious Adverse Events on Self Report Scale | Abdominal pain or cramping | 0.359 score on a scale | Standard Deviation 0.66 |
| Miralax | Non-Serious Adverse Events on Self Report Scale | Ability to complete entire prep | 1.878 score on a scale | Standard Deviation 0.39 |
| Miralax | Non-Serious Adverse Events on Self Report Scale | Difficulty/Inconvenience in completing prep | 0.6098 score on a scale | Standard Deviation 0.8 |
| Moviprep Split Dose | Non-Serious Adverse Events on Self Report Scale | Ability to complete entire prep | 1.8511 score on a scale | Standard Deviation 0.46 |
| Moviprep Split Dose | Non-Serious Adverse Events on Self Report Scale | Nausea | 0.3152 score on a scale | Standard Deviation 0.61 |
| Moviprep Split Dose | Non-Serious Adverse Events on Self Report Scale | Abdominal pain or cramping | 0.3043 score on a scale | Standard Deviation 0.66 |
| Moviprep Split Dose | Non-Serious Adverse Events on Self Report Scale | Vomiting | 0.0000 score on a scale | Standard Deviation 0 |
| Moviprep Split Dose | Non-Serious Adverse Events on Self Report Scale | Difficulty/Inconvenience in completing prep | 0.6596 score on a scale | Standard Deviation 0.75 |
| Moviprep Split Dose | Non-Serious Adverse Events on Self Report Scale | Bloating | 0.4565 score on a scale | Standard Deviation 0.72 |
Comparison: Nauseap-value: 0.772t-test, 2 sided
Comparison: Vomitingp-value: 0.028t-test, 2 sided
Comparison: Bloatingp-value: 0.235t-test, 2 sided
Comparison: Abdominal pain or crampingp-value: 0.707t-test, 2 sided
Comparison: Ability to complete entire prepp-value: 0.773t-test, 2 sided
Comparison: Difficulty/Inconvenience in completing prepp-value: 0.766t-test, 2 sided