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Bowel Preparation for Colonoscopy in Children

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ClinicalTrials.gov Identifier: NCT01140295
Recruitment Status : Terminated
First Posted : June 9, 2010
Results First Posted : April 12, 2013
Last Update Posted : April 12, 2013
Sponsor:
Information provided by (Responsible Party):
Petar Mamula, Children's Hospital of Philadelphia

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator)
Condition Colonoscopy Preparation
Intervention Drug: polyethylene glycol, senna
Enrollment 33
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.
Arm/Group Title 1, Miralax 2, Senna
Hide Arm/Group Description

Miralax colonoscopy preparation

Miralax (PEG-P) 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.

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.

Period Title: Overall Study
Started 17 16
Completed 16 14
Not Completed 1 2
Arm/Group Title 1, Miralax 2, Senna Total
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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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 17 16 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 16 participants 33 participants
<=18 years
17
 100.0%
16
 100.0%
33
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 16 participants 33 participants
12  (1.3) 15  (1.2) 14.5  (5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 16 participants 33 participants
Female
6
  35.3%
8
  50.0%
14
  42.4%
Male
11
  64.7%
8
  50.0%
19
  57.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants 16 participants 33 participants
17 16 33
1.Primary Outcome
Title Efficacy of Colon Preparation
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1, Miralax 2, Senna
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 17 16
Measure Type: Number
Unit of Measure: percentage of patients
88 28
2.Secondary Outcome
Title Proportion of Patients With Abnormal Electrolyte Levels
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1, Miralax 2, Senna
Hide Arm/Group Description:

Miralax colonoscopy preparation

Miralax (PEG-P) 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.

Senna colonoscopy preparation

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.

Overall Number of Participants Analyzed 17 16
Measure Type: Number
Unit of Measure: Proportion of patients
0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 1, Miralax 2, Senna
Hide Arm/Group Description

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.

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.

All-Cause Mortality
1, Miralax 2, Senna
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
1, Miralax 2, Senna
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/16 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
1, Miralax 2, Senna
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/16 (0.00%) 
Early termination due to poor efficacy in one of the study arms (senna preparation).
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Petar Mamula
Organization: The Children's Hospital of Philadelphia
Phone: 215-590-9146
Responsible Party: Petar Mamula, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01140295     History of Changes
Other Study ID Numbers: 2006-10-5004
First Submitted: June 1, 2010
First Posted: June 9, 2010
Results First Submitted: December 12, 2012
Results First Posted: April 12, 2013
Last Update Posted: April 12, 2013