Determination of the response rate to the drug (lactulose, bisacodyl) in acute cerebral stroke patients with acute constipation
Design
A clinical trial with community-based and pragmatic control group, with parallel and single blind, randomized, 45 patients in the control group and 45 patients in the intervention group will be included.
Settings and conduct
This is an interventional study on 45 patients with acute stroke. Patients will be checked on the second day after admission and will be questioned for the presence of defecation. Patients with constipation will randomly be assigned to either 30 ml or 20 gr lactulose or 10 mg bisacodyl pill. Patients will be evaluated for defication during the duration of admission (on average 5 days) and will be evaluated with the phone call if they are cleared earlier.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients with acute stroke (Diagnosed by a neurologist and confirmed by MRI or CT-Scan) who had new onset constipation during 48 hours.
Exclusion criteria:
- Previous history of chronic constipation or incontinence
- Previous history of colon or rectum cancer
- Metabolic cause of constipation (eg. Hypokalemia)
- Taking drugs induced constipation (eg. Anticholinergics or drugs with anticholinergic effects, calcium channel blockers and etc.)
- Previous history of diabetes mellitus or hypothyroidism
- Previous history of stroke and new symptoms due to metabolic derangement or acute infection
Intervention groups
Intervention group: Patients receiving Bisacodyl
Control group: Patients receiving Lactulose
Main outcome variables
Constipation improvement and response to treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181009041286N1
Registration date:2019-01-17, 1397/10/27
Registration timing:retrospective
Last update:2019-01-17, 1397/10/27
Update count:0
Registration date
2019-01-17, 1397/10/27
Registrant information
Name
reza Daneshvar kakhki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0026
Email address
daneshvar-r@mail.kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-07-23, 1397/05/01
Actual recruitment start date
2017-12-22, 1396/10/01
Actual recruitment end date
2018-07-23, 1397/05/01
Trial completion date
2018-08-01, 1397/05/10
Scientific title
Comparison of response to two regimens of Lactolose and Bisacodyl in the treatment of acute constipation in patients with acute stroke
Public title
The effects of laxative drugs in the treatment of acute constipation in patients with acute stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Admission within 48 hours of onset of symptoms
Definite stroke diagnosis and confirmation with CT-Scan or MRI
Acute constipation
Exclusion criteria:
Patients with constipation before stroke
History of colon or rectum cancer
Constipation caused by metabolic disorder such as hypokalemia
Taking drugs that cause constipation, such as anticholinergic drugs or drugs with anticholinergic effects, calcium blockers, etc.
History of diabetes mellitus
History of myocardial infarction
History of hypothyroidism
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
50
Actual sample size reached:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Selecting groups is completely random and will be done after matching. Randomization of patients will be done by file number using www.random.org site. On this site, the Gaussian randomization method was used with the normal distribution.
Blinding (investigator's opinion)
Single blinded
Blinding description
The Lactulose and Bisacodyl drugs are used in the same way with the same bottle, and patients will not be informed of the type of medication they receive.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Science
Street address
Pezeshk St., Ghotbe Ravandei ave.
City
Kashan
Province
Isfehan
Postal code
87159/81151
Approval date
2017-02-08, 1395/11/20
Ethics committee reference number
IR.KAUMS.REC.1395.047
Health conditions studied
1
Description of health condition studied
Acute constipation
ICD-10 code
K59.0
ICD-10 code description
Constipation
Primary outcomes
1
Description
Defication
Timepoint
Daily check for defication after taking drug
Method of measurement
Questionnaire designed by researcher
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group (Bisacodyl): Patients will receive 10 mg daily and will be evaluated for at least 5 days for response to treatment.
Category
Treatment - Drugs
2
Description
Control group (Lactulose): Patients will receive 20 gr equal to 15 ml syrup of lactulose daily and will be evaluated for at least 5 days for response to treatment.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashan Shahid Beheshtei hospital
Full name of responsible person
Reza Daneshvar Kakhki
Street address
Pezesh st., Ghotb e Ravandei ave.
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0026
Email
daneshvar-r@mail.kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Hamidreza Banafshe
Street address
Pezesh st., Ghotb e Ravandei Ave.
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5554 0021
Email
banafshe57@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Reza Daneshvar kakhki
Position
Assistant professor
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Neurology ward, Beheshtei general hospital, Kashan, Isfahan
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0026
Fax
Email
daneshvar-r@mail.kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Reza Daneshvar kakhki
Position
Assistant professor
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Neurology ward, Beheshtei general hospital, Kashan, Isfahan
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0026
Fax
Email
daneshvar-r@mail.kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Reza Daneshvar kakhki
Position
Assistant professor
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Neurology ward, Beheshtei general hospital, Kashan, Isfahan
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0026
Fax
Email
daneshvar-r@mail.kaums.ac.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
demographic data and outcome after deidentification will be available
When the data will become available and for how long
Data will be available from 2019 for 1 year
To whom data/document is available
For academic researchers, data will be available
Under which criteria data/document could be used
The use of data will be subject to obtaining a license from the University's Research and Technology Dept.
From where data/document is obtainable
neurology department, Shahid Beheshti General Hospital, Pezesh St., Ghotbe Ravandi Ave.
Postal Code: 8715981151
What processes are involved for a request to access data/document
Information will be obtained from the Department of Research and Technology of the University and correspondence with the Department of Neurology, Shahid Beheshti Hospital of Kashan.