Comparison assessment between one /two days clear liquid diet with Pydrolax and Bisacodil suppositore for bowel preparation for performing colonoscopy in children over two years referred to Pediatric Medical Center
The aim of this prospective double blinded randomized study was comparison assessment between one/ two day clear liquids with Pydrolax and Bisacodil suppository (group A and B)for performing colonoscopy on one hundred children over two years referred to endoscopy ward of Children Medical Centerfor a year except emergency colonoscopies.Patients satisfaction, regimens compliance ,relationship between defication frequency ,saline enema performance,colonoscopy completion and type of regimens and colonoscopy indication were also compared in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013121515802N1
Registration date:2014-01-03, 1392/10/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-01-03, 1392/10/13
Registrant information
Name
Sanaz Mehrabani
Name of organization / entity
Tehran University of Medical Sciences, pediatric medical center
Country
Iran (Islamic Republic of)
Phone
+98 21 61479
Email address
s-mehrabani@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-10-22, 1391/08/01
Expected recruitment end date
2013-10-23, 1392/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison assessment between one /two days clear liquid diet with Pydrolax and Bisacodil suppositore for bowel preparation for performing colonoscopy in children over two years referred to Pediatric Medical Center
Public title
Effect of Pydrolax and Bisacodil for bowel prepraration for colonoscopy in children
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:All of the children over two years; with colonoscopy indication.
Exclusion critria:Patients with cardiac;nephrologic; metabolic disorder; known case of allergy to Pydrolax/Bisacodil; clinical picture of moderate to severe colitis; fecal impaction; emergency colonoscopy.
Age
From 2 years old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran Univesity of Medical Sciences
Street address
Ghods street, Tehran University of Medical Sciences
City
Tehran
Postal code
14155/6447
Approval date
2013-05-18, 1392/02/28
Ethics committee reference number
1008
Health conditions studied
1
Description of health condition studied
Bowel preparation
ICD-10 code
Z43.4
ICD-10 code description
Attention to other artificial openings of digestive tract
Primary outcomes
1
Description
Quality of bowel preparation
Timepoint
After one or two days regime performance
Method of measurement
Boston bowel preparation
Secondary outcomes
1
Description
Regime side effects
Timepoint
After one or two days of regime performance
Method of measurement
Asking question from child or Parents
2
Description
Defication frequency
Timepoint
After one or two days of regime performance
Method of measurement
Asking question from child or Parents
3
Description
Regime compliance
Timepoint
After one or two days of regime performance
Method of measurement
Asking question from child or Parents
4
Description
Colonoscopy completion
Timepoint
After one or two days of regime performance
Method of measurement
Ability to inspect secum and terminal ileum
5
Description
Regime satisfaction
Timepoint
After one or two days of regime performance
Method of measurement
Asking question from child or Parents
Intervention groups
1
Description
Suggest oneday clear liquid with Pydrolax2 gr/kg/day divided in to two doses and Bisacodil suppository5 mg /BD to 50 patients a day before colonoscopy (groupA)
Category
Other
2
Description
Or suggest two day clear liquid wih Pydrolax 1/5 gr/kg /day divided in to two doses and Bisacodil suppository BD to other 50 patients two days before colonoscopy (group B)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Children Medical Center
Full name of responsible person
Dr Sanaz Mehrabani
Street address
Gharib street, Keshavarz Boulevard, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research center of Pediatric Medical Center
Full name of responsible person
DrAli Rabbani
Street address
Gharib street, Keshavarz Boulevard, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research center of Pediatric Medical Center
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
Tehran University of Medical Sciences Pediatric Medical Center
Full name of responsible person
Dr Sanaz Mehrabani
Position
Fellow of pediatric gastroenterology
Other areas of specialty/work
Street address
Gharib street, Keshavarz Boulevard, Tehran, Iran
City
Tehran
Postal code
1419733151
Phone
+98 21 61479
Fax
+98 21 6693 0024
Email
s-mehrabani@razi.tums.ac.ir chmc@tums.ac.ir
Web page address
chmc.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Siences Pediatric Medical Center
Full name of responsible person
Dr Mehri Najafi
Position
professor of pediatric gastroenterology
Other areas of specialty/work
Street address
Gharib street, Keshavarz Boulevard, Tehran, Iran
City
Tehran
Postal code
1419733151
Phone
+98 21 61479
Fax
+98 21 6693 0024
Email
chmc@tums .ac.ir najafisa@sina.tums.ac.ir
Web page address
chmc.tums .ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences Pediatric Medical Center
Full name of responsible person
Dr Sanaz Mehrabani
Position
Fellow of pediatric gastroenterology
Other areas of specialty/work
Street address
Gharib street, Keshavarz Boulevard, Tehran, Iran
City
Tehran
Postal code
1419733151
Phone
+98 21 61479
Fax
+98 21 6693 0024
Email
chmc@tums.ac.ir s-mehrabani@razi.tums.ac.ir
Web page address
chmc.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)