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

NCT01531140 | Completed Phase 4

• 1 other identifier: 1/2012
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

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.

Conditions

Colonoscopy Preparation

Keywords

colonoscopy cleansing; PEG; sennosides; children

Outcome Measures

Primary Outcomes (2)

• proportions of participants with good or excellent bowel preparation assessed with Ottawa Scale

  According to the Ottawa scale the quality of bowel preparation is estimated by adding points for the cleansing of three parts of colon (descending, transversal and ascending) and points for amount of fluid in the bowel. Score: 0-1 - excellent cleansing, 2-4 - good, 5-7 - sufficient, 8-10 - poor, 11-14 - not appropriate.

  bowel preparation quality with Ottawa scale is assesed during colonoscopy (3rd day of the study) by endoscopist blinded for the method of preparation

• proportions of participants with poor/inadequate bowel preparation assessed with Ottawa Scale

  According to the Ottawa scale the quality of bowel preparation is estimated by adding points for the cleansing of three parts of colon (descending, transversal and ascending) and points for amount of fluid in the bowel. Score: 0-1 - excellent cleansing, 2-4 - good, 5-7 - sufficient, 8-10 - poor, 11-14 - not appropriate.

  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 (5)

• proportions of participants with very good/good bowel preparation assessed with Aronchick Scale

  bowel preparation quality with Aronchick scale is assesed during colonoscopy (3rd day of the study) by endoscopist blinded for the method of preparation

• proportions of participants with poor/inadequate bowel preparation assessed with Aronchick Scale

  bowel preparation quality with Aronchick scale is assesed during colonoscopy (3rd day of the study) by endoscopist blinded for the method of preparation

• mean bowel preparation score assessed with Ottawa Scale

  bowel preparation quality with Ottawa scale is assesed during colonoscopy (3rd day of the study) by endoscopist blinded for the method of preparation

• mean bowel preparation score assessed with Aronchick scale

  bowel preparation quality with Aronchick scale is assesed during colonoscopy (3rd day of the study) by endoscopist blinded for the method of preparation

• patient satisfaction with the method of preparation assessed with Visual analogue scale (VAS)

  assessed by patient after completion of bowel preparation regimen before colonoscopy (3rd day of the study)

Study Arms (3)

Polyethylene glycol

ACTIVE COMPARATOR

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

Drug: Polyethylene glycol

PEG + Bisacodyl

EXPERIMENTAL

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

Drug: polyethylene glycol +Bisacodyl

Sennosides

EXPERIMENTAL

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

Drug: Sennosides

Interventions

polyethylene glycol +Bisacodyl DRUG

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

Also known as: Polyethylene glycol: Fortrans

PEG + Bisacodyl

Polyethylene glycol DRUG

Polyethylene glycol p.o.: 60 ml/kg/days

Also known as: Polyethylene glycol: Fortrans

Polyethylene glycol

Sennosides DRUG

Sennosides 1tbl/8kg for 2 days

Also known as: Sennosides: Xenna

Sennosides

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Warsaw: lead
• Institute of Child Health: collaborator

Study Sites (2)

Warsaw Medical University

Warsaw, 01-184, Poland

Location

Child Health Center

Warsaw, 04-730, Poland

Location

MeSH Terms

Interventions

Polyethylene Glycols; Sennosides

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Senna Extract; Anthraquinones; Anthrones; Anthracenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Quinones; Polycyclic Compounds; Glycosides; Carbohydrates; Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Piotr Dziechciarz, MD

  Medical University of Warsaw

  STUDY CHAIR

• Jaroslaw Kierkus, MD

  Child Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2012
• First Posted: February 10, 2012
• Study Start: November 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: February 10, 2012

Record last verified: 2012-01

Locations

PL (2)