PEG Versus PEG+Bisacodyl Versus Sennosides for Colon Cleansing Before Colonoscopy
Condition: Colonoscopy Preparation
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): polyethylene glycol +Bisacodyl; Polyethylene glycol; Sennosides
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Polyethylene glycol (Fortrans) p.o. 30 ml/kg/2days + Bisacodyl p.o.10-15 mg/day for 2 days; Polyethylene glycol p.o.: 60 ml/kg/days; Sennosides 1tbl/8kg for 2 days
Other intervention name(s): Polyethylene glycol: Fortrans; Polyethylene glycol: Fortrans; Sennosides: Xenna
Intervention MeSH terms: Bisacodyl; Senna Extract; Sennosides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: colonoscopy cleansing; PEG; sennosides; children