To evaluate the effect of oral pyridostigmine on ileus after abdominal surgery
Design
A single-blind clinical trial with a control group to determine randomized effect of the treatment
Settings and conduct
This study was performed in three sections of general surgery in Zahedan University of Medical Sciences. To this end, 40 patients were selected and divided into two groups of 20 patients each. A parallel intervention was daily conducted in both groups by the researcher's colleague and the patients were not aware of the type of group they were in.
Participants/Inclusion and exclusion criteria
The inclusion criteria were having ileus for more than 3 days and the consent to participate in the study. The exclusion criteria were heart rate less than 60 times per minute, blood pressure less than 90 mmHg, age below 18 years, finding mechanical causes for inactivity of the intestines, heart problem, colon cancer and small bowel cancer.
Intervention groups
Group One: (20 patients) Patients received oral pyridostigmine at a dose of 60 mg twice daily via NG TUBE.
Group two: (20 patients) the control group received starch twice daily via NG TUBE.
Main outcome variables
Treatment effect time: treatment effect frequency
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180123038484N1
Registration date:2018-02-17, 1396/11/28
Registration timing:retrospective
Last update:2018-02-17, 1396/11/28
Update count:0
Registration date
2018-02-17, 1396/11/28
Registrant information
Name
Abdobaset Malek Raeisi Nejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3522 3101
Email address
a.malek@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-01-21, 1393/11/01
Expected recruitment end date
2015-03-21, 1394/01/01
Actual recruitment start date
2015-01-21, 1393/11/01
Actual recruitment end date
2015-05-22, 1394/03/01
Trial completion date
empty
Scientific title
Evaluation of the effect of oral pyridostigmine on ileus after abdominal surgery
Public title
the effect of oral pyridostigmine on ileus after abdominal surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
having ileus for more than 3 days
the consent to participate in the study
Exclusion criteria:
heart rate less than 60 times per minute
blood pressure less than 90 mmHg
age below 18 years
finding mechanical causes for inactivity of the intestines
heart problem
colon cancer and small bowel cancer
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
randomized block sampling
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants: That is, patients are aware of being involved in the study, but not aware of which group they are in at the time of intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan university of medical sciences
Street address
Zahedan University of Medical Sciences, Dr Hesabi sq, Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9993134567
Approval date
2014-05-12, 1393/02/22
Ethics committee reference number
IR.ZAUMS.REC.1393.966
Health conditions studied
1
Description of health condition studied
postoperative ileus (poi)
ICD-10 code
K91.89
ICD-10 code description
Other postprocedural complications and disorders of digestive system
Primary outcomes
1
Description
Time for effectiveness
Timepoint
each hour
Method of measurement
Researcher-made questioner
2
Description
frequency of effectiveness
Timepoint
each hour
Method of measurement
Researcher-made questioner
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: (20 patients) Patients received oral pyridostigmine at a dose of 60 mg twice daily via NG TUBE.
Category
Treatment - Drugs
2
Description
Control group: (20 patients) the control group received starch twice daily via NG TUBE.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali hospital
Full name of responsible person
Alireza Khazaei
Street address
Zahedan University of Medical Sciences, Dr Hesabi sq, Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5796
Email
a.malek@zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mohsen Taheri
Street address
Zahedan University of Medical Sciences, Dr Hesabi sq, Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5796
Email
taheri@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Abdobaset Malek Raeisi Nejad
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Zahedan University of Medical Sciences, Dr Hesabi sq, Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3522 3101
Email
a.malek@zaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Alireza Khazaei
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Zahedan University of Medical Sciences, Dr Hesabi sq, Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3522 3101
Email
alireza-khazaei@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Abdobaset Malek Raeisi Nejad
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Zahedan University of Medical Sciences, Dr Hesabi sq, Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3522 3101
Email
a.malek@zaums.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
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Some part of data
When the data will become available and for how long
Start of access to data from six months after publishing the paper.
To whom data/document is available
Universities
Under which criteria data/document could be used
for more analysis only for some parts.
From where data/document is obtainable
PI Email: a.malek@zaums.ac.ir
What processes are involved for a request to access data/document