PEG Versus PEG+Bisacodyl Versus Sennosides for Colon Cleansing Before Colonoscopy

Medical University of Warsaw

Status and phase: Completed; Phase 4

Conditions: Colonoscopy Preparation

Treatments: Drug: Sennosides; Drug: polyethylene glycol +Bisacodyl; Drug: Polyethylene glycol

Study type: Interventional

Funder types: Other

Identifiers

NCT01531140

1/2012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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240 participants in 3 patient groups

Polyethylene glycol

Active Comparator group

Description:

Polyethylene glycol p.o.(Fortrans):60 ml/kg for 2 days

Treatment:

Drug: Polyethylene glycol

PEG + Bisacodyl

Experimental group

Description:

Polyethylene glycol p.o.(Fortrans): 30 ml/kg for 2 days + Bisacodyl p.o.: 10-15 mg/day

Treatment:

Drug: polyethylene glycol +Bisacodyl

Sennosides

Experimental group

Description:

Sennosides: 1tbl/8kg/day for 2 days (1 tbl=8,6 mg sennosides B)

Treatment:

Drug: Sennosides