Colonoscopy Preparation
Conditions
Keywords
Preparation, Pediatric, Colonoscopy
Brief summary
The primary objective of this study is to determine whether Miralax results in a more efficacious preparation as compared to senna for pediatric colonoscopy.
Detailed description
Study subjects will be randomized in two groups: Group one will receive 1.5 g/kg of Miralax orally the day before procedure and one day of clear liquid diet, while subjects in Group 2 will receive two doses of senna the day before procedure with two days of liquid diet (one day full liquid and one day clear liquid diet). On the day of the procedure parents/subjects will complete a questionnaire regarding prep compliance and adverse events. Electrolytes will be obtained prior to colonoscopy to monitor for electrolyte imbalance. Endoscopists will assess preparation for colonoscopy using validated cleanliness scale (Aronchick scale).
Interventions
DRUGpolyethylene glycol, senna
Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age \>12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure. Miralax at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days.
Sponsors
Children's Hospital of Philadelphia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects age 6-21 yrs for senna, PEG-P groups 2. Subjects age 13-21 yrs for NaP group 3. First time colonoscopy 4. Patient weight \<70 kg for PEG-P group (to not exceed 51 grams/dose)
Exclusion criteria
1. Chronic renal, liver, or heart failure 2. Chronic constipation 3. Patients on the GI inpatient or consult service. 4. Subjects taking senna or PEG on a regular basis for laxative reasons. 5. Pregnant or lactating females
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of Colon Preparation | The outcome measure will be assessed once one day after the completion of colonoscopy preparation | Percentage of patients with excellent or good colonoscopy preparation. The efficacy of preparation is measured by using a validated colon cleanliness scale which has 5 different levels (Aronchik scale). Levels 1 and 2, which encompass excellent and good colonoscopy preparation, are routinely recognized as adequate preparation allowing for successful completion of colonoscopy. Levels 3-5 describe incomplete or poor preparation. These levels are associated with significant residual stool encountered at the time of colonoscopy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients With Abnormal Electrolyte Levels | The outcome measure will be assessed once one day after the completion of colonoscopy preparation | The outcome measure was comparison of the proportions of patients who had abnormal electrolyte levels between two groups of patients, Miralax and senna. Sodium, potassium, chloride, and carbon dioxide levels were measured in mmol/L while urea nitrogen, creatinine, glucose, calcium, magnesium, and phosphorus were measured in mg/dL. Each of these values has a reference range which varies with patients' age and sex. Minimal change of one point above or below normal reference range was dismissed as clinically insignificant. Abnormal creatinine levels were rechecked through glomerular filtration rate calculation to determine if there was any compromise in renal function since abnormal creatinine level does not mean there is renal dysfunction nor that the level is clinically significant. |
Countries
United States
Participant flow
Recruitment details
Patients were recruited at The Children's Hospital of Philadelphia Main site Endoscopy suite from September 2010 to April 2011.
Pre-assignment details
365 patients were screened. 98 were eligible according to inclusion/exclusion criteria. 41 declined participation. criteria. Of the 57 eligible patients 33 were enrolled when the study was prematurely terminated.
Participants by arm
| Arm | Count |
|---|---|
| 1, Miralax Miralax colonoscopy preparation
polyethylene glycol, senna : Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age \>12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure.
Miralax at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days. | 17 |
| 2, Senna Senna colonoscopy preparation
polyethylene glycol, senna : Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age \>12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure.
Miralax at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days. | 16 |
| Total | 33 |
Baseline characteristics
| Characteristic | 2, Senna | 1, Miralax | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 16 Participants | 17 Participants | 33 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age Continuous | 15 years STANDARD_DEVIATION 1.2 | 12 years STANDARD_DEVIATION 1.3 | 14.5 years STANDARD_DEVIATION 5 |
| Region of Enrollment United States | 16 participants | 17 participants | 33 participants |
| Sex: Female, Male Female | 8 Participants | 6 Participants | 14 Participants |
| Sex: Female, Male Male | 8 Participants | 11 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 17 | 0 / 16 |
| serious Total, serious adverse events | 0 / 17 | 0 / 16 |
Outcome results
Primary
Efficacy of Colon Preparation
Percentage of patients with excellent or good colonoscopy preparation. The efficacy of preparation is measured by using a validated colon cleanliness scale which has 5 different levels (Aronchik scale). Levels 1 and 2, which encompass excellent and good colonoscopy preparation, are routinely recognized as adequate preparation allowing for successful completion of colonoscopy. Levels 3-5 describe incomplete or poor preparation. These levels are associated with significant residual stool encountered at the time of colonoscopy.
Time frame: The outcome measure will be assessed once one day after the completion of colonoscopy preparation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1, Miralax | Efficacy of Colon Preparation | 88 percentage of patients |
| 2, Senna | Efficacy of Colon Preparation | 28 percentage of patients |
Secondary
Proportion of Patients With Abnormal Electrolyte Levels
The outcome measure was comparison of the proportions of patients who had abnormal electrolyte levels between two groups of patients, Miralax and senna. Sodium, potassium, chloride, and carbon dioxide levels were measured in mmol/L while urea nitrogen, creatinine, glucose, calcium, magnesium, and phosphorus were measured in mg/dL. Each of these values has a reference range which varies with patients' age and sex. Minimal change of one point above or below normal reference range was dismissed as clinically insignificant. Abnormal creatinine levels were rechecked through glomerular filtration rate calculation to determine if there was any compromise in renal function since abnormal creatinine level does not mean there is renal dysfunction nor that the level is clinically significant.
Time frame: The outcome measure will be assessed once one day after the completion of colonoscopy preparation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1, Miralax | Proportion of Patients With Abnormal Electrolyte Levels | 0 Proportion of patients |
| 2, Senna | Proportion of Patients With Abnormal Electrolyte Levels | 0 Proportion of patients |