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

Colonoscopy Preparation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01531140
• Other study ID #: 1/2012
• Status: Completed
• Phase: Phase 4
• First received: January 16, 2012
• Last updated: February 9, 2012
• Start date: November 2010
• Est. completion date: November 2011

Study information

• Verified date: January 2012
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Science and Higher Education
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 18 Years

Eligibility

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.)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colonoscopy Preparation

Intervention

Drug:
• polyethylene glycol +Bisacodyl
Polyethylene glycol (Fortrans) p.o. 30 ml/kg/2days + Bisacodyl p.o.10-15 mg/day for 2 days
• Polyethylene glycol
Polyethylene glycol p.o.: 60 ml/kg/days
• Sennosides
Sennosides 1tbl/8kg for 2 days

Locations

Country	Name	City	State
Poland	Child Health Center	Warsaw
Poland	Warsaw Medical University	Warsaw

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Warsaw	Institute of Child Health

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	proportions of participants with very good/good bowel preparation assessed with Aronchick Scale	According to Aronchick scale preparation is estimated as: very good: small amount of clear fluid is present, more than 95% mucosa is visible; good: small amount of clear fluid easy to suction away or flush is present, more than 90% of mucosa is visible; sufficient: big amount of clear fluid covering 5-25% of mucosa, more than 90% of mucosa visible; poor: semi-liquid stool that cannot be flushed, less than 90% of mucosa visible; inadequate: colonoscopy must be repeated	bowel preparation quality with Aronchick scale is assesed during colonoscopy (3rd day of the study) by endoscopist blinded for the method of preparation	No
Secondary	proportions of participants with poor/inadequate bowel preparation assessed with Aronchick Scale	According to Aronchick scale preparation is estimated as: very good: small amount of clear fluid is present, more than 95% mucosa is visible; good: small amount of clear fluid easy to suction away or flush is present, more than 90% of mucosa is visible; sufficient: big amount of clear fluid covering 5-25% of mucosa, more than 90% of mucosa visible; poor: semi-liquid stool that cannot be flushed, less than 90% of mucosa visible; inadequate: colonoscopy must be repeated	bowel preparation quality with Aronchick scale is assesed during colonoscopy (3rd day of the study) by endoscopist blinded for the method of preparation	No
Secondary	mean bowel preparation score 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	No
Secondary	mean bowel preparation score assessed with Aronchick scale	According to Aronchick scale preparation is estimated as: very good: small amount of clear fluid is present, more than 95% mucosa is visible; good: small amount of clear fluid easy to suction away or flush is present, more than 90% of mucosa is visible; sufficient: big amount of clear fluid covering 5-25% of mucosa, more than 90% of mucosa visible; poor: semi-liquid stool that cannot be flushed, less than 90% of mucosa visible; inadequate: colonoscopy must be repeated	bowel preparation quality with Aronchick scale is assesed during colonoscopy (3rd day of the study) by endoscopist blinded for the method of preparation	No
Secondary	patient satisfaction with the method of preparation assessed with Visual analogue scale (VAS)	VAS scale is horizontal line 100 mm lenght anchored by word description at each end (very good, very bad).The patient mark on the line the point that feel represent the perception of bowel preparation regimen.	assessed by patient after completion of bowel preparation regimen before colonoscopy (3rd day of the study)	No