Comparison of the three one day colon preparation methods with oral PEG, oral PEG plus bisacodyl suppository and oral PEG plus saline enema for colonoscopy in children
Aim: In this study three methods for bowel preparation will be compared. Preparation score will be assessed according to validated Boston Bowel Preparation Score.
Inclusion criteria: All children aged 2-21 years old who have indication for colonoscopy
Exclusion criteria:Parental disagreement; History of previous gastrointestinal surgery; History of previous bowel preparation in 2 weeks; Uncooperative patients
Sample size: Thirty cases in each group will be studied.
Intervention:
Group I: For children weighed equal or greater than 45kg, 280 gram of polyethylene glycol per 2 liter mineral water will be administered orally. For children weighed < 45 kg, 140 gram of PEG per 1 liter of mineral water will be administered orally.
Group 2: In addition to PEG as mentioned above, 5 mg bisacodyl suppository will be used three times at q8hr before colonoscopy.
Group 3: In addition to PEG, 500 cc normal saline enema will be used two times at 12 hr interval before colonoscopy.
Bowel preparation will be evaluated according to Boston Bowel Preparation Scale. The minimum and maximum of scores for whole large bowel are 0-9. The maximum of score for each part of colon is 3.
0= Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared.
1= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool and/or opaque liquid.
2 = Minor amount of residual staining, small fragments of stool and/or opaque liquid, but
mucosa of colon segment seen well.
3 = Entire mucosa of colon segment seen well with no residual staining, small fragments
of stool or opaque liquid
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014110919881N1
Registration date:2014-12-04, 1393/09/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-12-04, 1393/09/13
Registrant information
Name
Hazhir Javaherizadeh
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4298
Email address
javaherizadeh-h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
This study was supported by Shiraz University of Medical Sciences
Expected recruitment start date
2014-12-01, 1393/09/10
Expected recruitment end date
2015-06-01, 1394/03/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the three one day colon preparation methods with oral PEG, oral PEG plus bisacodyl suppository and oral PEG plus saline enema for colonoscopy in children
Public title
Comparison of three different methods for bowel preparation
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: All children aged 2-21 years old who have indication for colonoscopy
Exclusion criteria: Parental disagreement; History of previous gastrointestinal surgery; History of previous bowel preparation in 2 weeks; Uncooperative patients
Age
From 2 years old to 21 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand St., Shiraz, Iran
City
Shiraz
Postal code
Approval date
2014-11-02, 1393/08/11
Ethics committee reference number
CT-P-9365-6845
Health conditions studied
1
Description of health condition studied
Bowel preparation before colonoscopy
ICD-10 code
K62.5
ICD-10 code description
Haemorrhage of anus and rectum
2
Description of health condition studied
Bowel preparation- Ulcerative colitis
ICD-10 code
K51
ICD-10 code description
Ulcerative colitis
Primary outcomes
1
Description
Boston Bowel Preparation Scale
Timepoint
During colonoscopy
Method of measurement
With observation according to validated scale
Secondary outcomes
1
Description
None
Timepoint
None
Method of measurement
None
Intervention groups
1
Description
Group I: Oral polyethyelene glycol will be used for bowel preparation starting from 4 pm one day before colonoscopy. For children weighed >=45 kg, 280 gr of polyethylene glycol will be used. For children <45 kg, 140 gram of PEG will be used.
Category
Treatment - Drugs
2
Description
Group II. Oral polyethyelene glycol will be used for bowel preparation starting from 4 pm one day before colonoscopy. For children weighed >=45 kg, 280 gr of polyethylene glycol will be used. For children <45 kg, 140 gram of PEG will be used. In addition to PEG, bisacodyl suppository (5mg) will be used three times (at 8hr interval) in the day before colonoscopy.
Category
Treatment - Drugs
3
Description
Group III: Oral polyethyelene glycol will be used for bowel preparation starting from 4 pm one day before colonoscopy. For children weighed >=45 kg, 280 gr of polyethylene glycol will be used. For children <45 kg, 140 gram of PEG will be used. Normal saline (500 cc) at 12 hr interval in two dosage will be used.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dept. of Pediatric Gastroenterology, Namazi Hospital
Full name of responsible person
Hazhir Javaherizadeh
Street address
Dept. of Pediatric Gastroenterology, Namazi Hospital, Namazi Sq, Shiraz, Iran
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hazhir Javaherizadeh
Street address
Dept. of Pediatric Gastroenterology, Namazi Hospital
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hazhir Javaherizadeh
Position
Fellowship of Pediatric Gastroenterology
Other areas of specialty/work
Street address
Dept. of Pediatric Gastroenterology, Namazi Hospital, Namazi Sq, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 3647 4298
Fax
Email
javaherizadeh-h@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hazhir Javaherizadeh
Position
Fellow of Pediatric Gastroenterology
Other areas of specialty/work
Street address
Dept. of Pediatric Gastroenterology, Namazi Hospital, Shiraz University of Medical Sciences
City
Shiraz
Postal code
Phone
+98 71 3647 4298
Fax
Email
javaherizadeh-h@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hazhir Javaherizadeh
Position
Fellow of Pediatric Gastroenterology
Other areas of specialty/work
Street address
Dept. of Pediatric Gastroenterology, Namazi Hospital
City
Shiraz
Postal code
Phone
00
Fax
Email
Javaherizadeh-h@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)