The determination and comparison of the findings in both groups (with or with out sedative drugs)based on sex and age
Design
A clinical trial study including an applicable control group based on the society which is in line with other parallel groups.
Settings and conduct
This study will be conducted on patients of the colonoscopy ward at AL Zahra hospital and a private clinic in 2019.
Patients are divided into two groups each containing 120.
They will go through colonoscopy operations using different indications like digestive hemorrhage ,defecation and urine patterns, anemia,and iron deficiency.
Participants/Inclusion and exclusion criteria
The acceptance factors are being above 18 years and the existence of other standard indications of colonoscopy like digestive hemorrhage ,defecation and urine patterns, stomachache,anemia,iron deficiency ,colon cancer screening tests ,and the informed consent.
The factors for non acceptance of the testes are as follow:
Reluctance to continue the study, the non readiness of bowels, any background of colon surgeries , allergy to sedative drugs, cardiovascular instability, the size of colon tumor which can make the operation impossible.
Intervention groups
The ideal purpose of colonoscopy without sedatives is a meticulous examination of a patient without using any sedative drugs.it has many advantages.The studies reveal that a non sedative colonoscopy which is conducted meticulously can rarely cause any side effects and can include a large number of patients.
Main outcome variables
To determine the best method of colonoscopy in patients with the most findings and the least side effects.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190105042246N1
Registration date:2019-02-01, 1397/11/12
Registration timing:prospective
Last update:2019-02-01, 1397/11/12
Update count:0
Registration date
2019-02-01, 1397/11/12
Registrant information
Name
seid javad shariaat nabavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3552 3631
Email address
sjshn@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-04, 1397/11/15
Expected recruitment end date
2019-03-06, 1397/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comperative study of colonoscopic findings and effects in groups with/without traquilizing drug based on age and sex
Public title
The study of not using the anesthesia in colonoscipic effects and findings
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age above 18 years
Colonoscopy standard indications like digestive hemorrhage
Any change in defecation and urination pattern , stomachache,anemia,iron deficiency,and pre cancer examination
Bowels readiness to go through the colonoscopy operation
Willingness to fill the informed consent
Exclusion criteria:
Reluctance to pursue the study
Bowels are not ready
The patients colon surgery background
Allergy to sedative drugs
Heart and arteries stability
Colon tumor blockade which makes the surgery impossible
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
240
Randomization (investigator's opinion)
Randomized
Randomization description
Sequential sampling procedure and randomization is based on the table of random number
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
The research ethics committee of the medical science university
Street address
Isfahan university of medicine,the centeral unit,Hezar Jarib Street, Isfahan,Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2018-12-22, 1397/10/01
Ethics committee reference number
397405
Health conditions studied
1
Description of health condition studied
colonoscopy with and without sedation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sedation in colonoscopy
Timepoint
Up to 24 hours after colonoscopy
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Use of sedation
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
بیمارستان الزهرا
Full name of responsible person
Ahmad Shavakhi
Street address
Soffeh Blvd.,Isfahan,Iran
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
alzahra@mui.ac.ir
Web page address
http://alzahra.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mansor Siavash
Street address
Isfahan university of medicine,Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
Arashrad57@yahoo.com
Web page address
http://mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Ahmad shavakhi
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Isfahan university of medicine,Hezar Jarib Street,
City
Isfahan
Province
Isfehan
Postal code
8175997571
Phone
+98 312336621
Email
ashvakhi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ahmad Shavakhi
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Hezar Jarib street,Isfahan,Iran
City
Isfahan
Province
Isfehan
Postal code
8175997571
Phone
+98 312336621
Email
ashavakhi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ahmad shavakhi
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Isfahan university of medicine,Hezar Jarib Street,
City
Isfahan
Province
Isfehan
Postal code
8175997571
Phone
+98 312336621
Email
ashvakhi@yahoo.com
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
It is necessary that all the applicants remain unknown.All the data including the side effects and advantages are to be published completely
When the data will become available and for how long
The data is promptly available after being published
To whom data/document is available
All the researchers, physicians,and anyone interested can send a request
Under which criteria data/document could be used
There will be some negotiations after receiving the data
From where data/document is obtainable
Applicants can send an email using ashavakhi@yahoo.com
They can make calls using this number 09163163224 or go in person to the endoscopy ward of Alzahra Hospital
What processes are involved for a request to access data/document
There will be some negotiations with the applicant after sending the request.He will be informed about how to receive the data as soon as possible.