Comparison of clear liquid versus low fiber diet regimen for colonoscopy preparation
Design
A randomized, blinded, controlled clinical trial with a parallel group design of 100 patients.
Settings and conduct
In this study, patients are divided two groups: one group receives a clear liquid diet and pidrolax powder and bisacodyl tablets, and the second group receives a low-fiber diet and pidrolax powder and bisacodyl tablets. The next morning, colonoscopy is performed by a pediatric gastroenterologist. Resident and gastroenterologist assess intestinal preparation with Boston bowel preparation.
Participants/Inclusion and exclusion criteria
2-14 years old children referred to Amirkola pediatric hospital
Heart disease, renal disease, metabolic disease, allergy to poly ethylene glycol
Intervention groups
Comparison of clear liquid versus low fiber diet regimen
Clear liquid: chicken water, broth, soup, fruit juice, tea
Low fiber: milk, dairy, soft bread, honey
Main outcome variables
Quality of bowel cleansing, gastrointestinal complications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210505051185N1
Registration date:2021-05-22, 1400/03/01
Registration timing:registered_while_recruiting
Last update:2021-05-22, 1400/03/01
Update count:0
Registration date
2021-05-22, 1400/03/01
Registrant information
Name
Setareh Kamel
Name of organization / entity
The university of babol
Country
Iran (Islamic Republic of)
Phone
+98 11 4227 3143
Email address
dsenshenas@chmail.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of clear liquid versus low fiber diet regimen for colonoscopy preparation 2-14 years old children referred to Amirkola pediatric hospital
Public title
Comparison of clear liquid and low fiber diet regimen for colonoscopy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Children 2 to 14 years old are candidates for colonoscopy referred to Amirkola Children's Hospital
Participants do not know how patients choose to receive the diet.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of babol University of Medical Sciences
Street address
Shafizade Ave., Emam Blvd., Babol Town
City
Babol
Province
Mazandaran
Postal code
4766161685
Approval date
2021-03-13, 1399/12/23
Ethics committee reference number
IR.MUBABOL.REC.1399.505
Health conditions studied
1
Description of health condition studied
Colonoscopy preparation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Intestinal cleansing
Timepoint
After colonoscopy
Method of measurement
Boston bowel preparation
Secondary outcomes
1
Description
Regimen complications
Timepoint
After colonoscopy
Method of measurement
Visual Analogue Scale
Intervention groups
1
Description
Intervention group:Before colonoscopy, One group receive clear liquids diet and Pidrolax powder 2 grams per kilogram of weight made by Sepidaj Karaj factory and bisacodyl tablets. The next morning, colonoscopy is performed by a gastroenterologist using the Olympus CE-H17.L machine made in Japan. After a colonoscopy, the doctor and nurse assess the bowel preparation by Boston Bowel preparation score.
Category
Rehabilitation
2
Description
Intervention group:Before colonoscopy, Second group receive low fiber diet and Pidrolax powder 2 grams per kilogram of weight made by Sepidaj Karaj factory and bisacodyl tablets. The next morning, colonoscopy is performed by a gastroenterologist using the Olympus CE-H17.L machine made in Japan. After a colonoscopy, the doctor and nurse assess the bowel preparation by Boston Bowel preparation score.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkola pediatric hospital
Full name of responsible person
Setareh kamel
Street address
Shafizade Ave., Emam Blvd., Babol Town
City
Babol
Province
Mazandaran
Postal code
4766161685
Phone
+98 11 3235 4951
Email
dsenshenas@chmail.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Sanaz mehrabani tabari
Street address
Shafizade Ave., Emam Blvd., Babol Town
City
Babol
Province
Mazandaran
Postal code
4766161685
Phone
+98 11 3235 4951
Email
Mehrabanisanaz@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Setareh Kamel
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Shafizade Ave., Emam Blvd., Babol Town
City
Babol
Province
Mazandaran
Postal code
4766161685
Phone
+98 11 3235 4951
Email
dsenshenas@chmail.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Setareh kamel
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Shafizade Ave., Emam Blvd., Babol Town
City
Babol
Province
Mazandaran
Postal code
476616165
Phone
+98 11 3235 4951
Email
dsenshenas@chmail.ir
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Sanaz mehrabani tabari
Position
Associated professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Shafizade Ave., Emam Blvd., Babol Town
City
Babol
Province
Mazandaran
Postal code
4766161685
Phone
+98 11 3235 4951
Email
dsenshenas@chmail.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The main outcome information can be shared
When the data will become available and for how long
6 months after printing the results
To whom data/document is available
Pediatric doctors
Under which criteria data/document could be used
For colonoscopy preparation
From where data/document is obtainable
Setareh kamel
What processes are involved for a request to access data/document
Inform the resident and the permission of the above gastroenterology specialist