(1) Objectives: Comparing the effect of PEG and C-Lax in bowel preparation
(2) Design: In this single center randomized double blind clinical trial, 300 eligible cases will randomly allocated to either of the 2 groups by endoscopy technician
(3) Setting and conduct: In this study, among all patients candidate for colonoscopy exam in our academic hospital, 300 eligible cases will randomly allocated in either PEG or C-lax group to compare the effect of these two agents in bowel preparation by Ottawa score
(4) Participants: All patients refereed for colonoscopy without heart failure, non-pregnant, no history of colectomy, older than 18 years-old
(5) Intervention: Administration of PEG and C-Lax
(6) Main outcome measures: Ottawa score (score and quality of bowel preparation)
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201601161264N7
Registration date:2016-02-04, 1394/11/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-02-04, 1394/11/15
Registrant information
Name
Sima Besharat
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 1224 4170
Email address
besharat@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Golestan University of Medical Sciences
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized double blind clinical trial to compare the effect of polyethylene glycol and C-lax in bowel preparation for colonoscopy
Public title
Comparing the effect of polyethylene glycol and C-lax in bowel preparation for colonoscopy
Purpose
Diagnostic
Inclusion/Exclusion criteria
Exclusion criteria: Age less than 18 years; history of colectomy; any contraindication for colonoscopy (compromised congestive heart disease (class III and IV of American Heart Association); severe mental disease; pregnancy and lactation; patients' not willing to participate
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
300
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
Golestan University of Medical Sciences
Street address
Research deputy, Falsafi educational complex, Shastkola road
City
Gorgan
Postal code
Approval date
2014-08-20, 1393/05/29
Ethics committee reference number
32189210226
Health conditions studied
1
Description of health condition studied
Bowel functional disorders
ICD-10 code
K92.8
ICD-10 code description
Other specified diseases of digestive system
Primary outcomes
1
Description
The quality of bowel preparation
Timepoint
At the time of colonoscopy
Method of measurement
Ottawa score
Secondary outcomes
empty
Intervention groups
1
Description
Sachets of PEG powder rinsed in water (each sachet contains 70 grams of PEG rinsed in 4 glasses of water) , and patients will be asked to drink 250 mL of the solution every 15 minutes starting 24 hours before the procedure.
Category
Diagnosis
2
Description
In C-lax group, 3 bottles of C-lax syrup (each 60 mL bottle contains 90 mg Senozoids) in two split dose beginning from 24 before the procedure (1.5 bottles at 9 am and 1.5 bottles at 5 pm the day before colonoscopy).
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Sayyad-e-Shirazi Hospital
Full name of responsible person
Street address
City
Gorgan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Hossein Taziki
Street address
Falsafi educational complex, Shastkola road
City
Gorgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Golestan 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
Golestan University of Medical Sciences
Full name of responsible person
Alireza Norouzi
Position
MD, Gastroentrologist
Other areas of specialty/work
Street address
GI department, Sayyad-e-Shirazi Hospital
City
Gorgan
Postal code
Phone
+98 17 3234 0835
Fax
Email
norouzi54@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Alireza Norouzi
Position
MD
Other areas of specialty/work
Street address
GI department, Sayyad-e-Shirazi Hospital
City
Gorgan
Postal code
Phone
+98 17 3234 0835
Fax
Email
norouzi54@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Sima Besharat
Position
MD, PhD
Other areas of specialty/work
Street address
Third floor, Research centers' complex, Tenth Azar alley, Fifth Azar St
City
Gorgan
Postal code
Phone
+98 17 3234 0835
Fax
Email
s_besharat_gp@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)