Bowel Preparation for Colonoscopy in Children

Phase 4

Terminated

• Conditions: Colonoscopy Preparation
• Interventions: Drug: polyethylene glycol, senna

• Registration Number: NCT01140295
• Lead Sponsor: Children's Hospital of Philadelphia

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).

Study Timeline

• Study First Submitted: 2010-06-01
• Study First Submitted QC: 2010-06-08
• Study First Posted: 2010-06-09
• Study Start: 2010-09
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Results First Submitted: 2012-12-12
• Status Verified: 2013-04
• Results First Submitted QC: 2013-04-10
• Last Update Submitted: 2013-04-10
• Results First Posted: 2013-04-12
• Last Update Posted: 2013-04-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1, Miralax	polyethylene glycol, senna	Miralax colonoscopy preparation
2, senna	polyethylene glycol, senna	Senna colonoscopy preparation

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

The Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States