Clinical trial NCT01531140: PEG Versus PEG+Bisacodyl Versus Sennosides for Colon Cleansing Before Colonoscopy
Official title: High-volume Polyethylene Glycol Solution (PEG) Versus Low-volume PEG Plus Stimulant Laxative Versus Sennosides for Colon Cleansing Before Colonoscopy: a Randomized, Single Blinded Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colonoscopy Preparation
Keywords: colonoscopy cleansing
PEG
sennosides
children
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
Collaborators: name: Institute of Child Health
First posted: 2012-02-10
Enrollment: 240
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background:

Polyethylene glycol (PEG) solution has been proven to be effective for large bowel cleansing prior to colonoscopy in children. However, the high volume of fluid and its taste sometimes lead to inappropriate cleansing of the bowel, thus search for other bowel preparation is needed.

Aim:

The efficacy and tolerability of three different bowel cleansing protocols used in children for colonoscopy: high-volume PEG compared with low-volume PEG with stimulant laxative (bisacodyl) compared with sennosides.

Methods:

Participants aged 10-18 years will be randomly assigned to receive either PEG 60 ml/kg/day or PEG 30 ml/kg/day plus oral bisacodyl 10-15 mg/day or sennosides 2mg/kg/day for 2 days prior to the colonoscopy. The outcome measures will be:bowel cleansing efficacy, scored by a blinded endoscopist using the Ottawa scale and Aronchick Scale (the mean total score, proportions of participants with excellent/good and with poor/inadequate bowel preparation), and the patient satisfaction score(0-10)with the method of preparation for the colonoscopy evaluated with the visual analog scale. Analysis will be done on an intention to treat basis.

Detailed description: Patients are excluded if they had known allergy to one of the tested preparations such as bisacodyl (Bisacodyl VP, ICN Polfa, Rzeszow, Poland), polyethylene glycol (Fortrans, Beaufour Ipsen Industry, Dreux, France) and/or sennoside (Xenna Extra, US Pharmacia, Wroclaw, Poland) and had disorders that make oral intake of the preparation impossible (neurological disorders, intestinal obstruction, mental retardation etc.).

Study design:

On admission day patients are allocated to one of the groups by study investigators, according to the randomization list created by an independent person using block randomization by a standard statistical program StatsDirect \[version 2,3,8 (2005)\] (6 patients were included in each block).

During the preparation for colonoscopy each patient are observed for procedure tolerance. On the day of endoscopy, each patient evaluated the degree of the acceptance of the method of bowel cleaning (according to visual analog scale (VAS) and the occurrence of side effects (diary). The endoscopist performing colonoscopy, blinded for the bowel preparation regimen evaluate bowel cleansing and score it, according to the Aronchick and Ottawa scale. The rate of cecum intubation, and the colonoscopy complications (defined as bowel perforation and/or significant bleeding) are analyzed in each bowel preparation group.

Eligibility criteria: Inclusion Criteria:

* children 10 - 18 years of age referred for colonoscopy
* informed consent signed

Exclusion Criteria:

* allergy to PEG, sennosides or bisacodyl
* disorders that make oral intake of the preparation impossible (neurological disorders, intestinal obstruction, mental retardation etc.)

Primary outcomes:
measure: proportions of participants with good or excellent bowel preparation assessed with Ottawa Scale
timeFrame: bowel preparation quality with Ottawa scale is assesed during colonoscopy (3rd day of the study) by endoscopist blinded for the method of preparation
measure: proportions of participants with poor/inadequate bowel preparation assessed with Ottawa Scale
timeFrame: bowel preparation quality with Ottawa scale is assesed during colonoscopy (3rd day of the study) by endoscopist blinded for the method of preparation
Secondary outcomes:
measure: proportions of participants with very good/good bowel preparation assessed with Aronchick Scale
timeFrame: bowel preparation quality with Aronchick scale is assesed during colonoscopy (3rd day of the study) by endoscopist blinded for the method of preparation
measure: proportions of participants with poor/inadequate bowel preparation assessed with Aronchick Scale
timeFrame: bowel preparation quality with Aronchick scale is assesed during colonoscopy (3rd day of the study) by endoscopist blinded for the method of preparation
measure: mean bowel preparation score assessed with Ottawa Scale
timeFrame: bowel preparation quality with Ottawa scale is assesed during colonoscopy (3rd day of the study) by endoscopist blinded for the method of preparation
measure: mean bowel preparation score assessed with Aronchick scale
timeFrame: bowel preparation quality with Aronchick scale is assesed during colonoscopy (3rd day of the study) by endoscopist blinded for the method of preparation
measure: patient satisfaction with the method of preparation assessed with Visual analogue scale (VAS)
timeFrame: assessed by patient after completion of bowel preparation regimen before colonoscopy (3rd day of the study)
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Warsaw Medical University
city: Warsaw
country: Poland
facility: Child Health Center
Study officials:
affiliation: Medical University of Warsaw
name: Piotr Dziechciarz, MD
role: STUDY_CHAIR
affiliation: Child Health Center
name: Jaroslaw Kierkus, MD
role: PRINCIPAL_INVESTIGATOR
References: