Study of the effect of perioperative strict blood glucose control before, during and after spinal surgery (posterior approach)in elective diabetic or glucose intolerance patients on the decrease of surgical site infection
Study of the effect of perioperative strict blood glucose control before, during and after spinal surgery (posterior approach)in elective diabetic or glucose intolerance patients on the decrease of surgical site infection
Design
This study is a one-blinded clinical trial. The study population will be included all patients with diabetes undergoing posterior approach spinal surgery referred to Imam Reza hospital of Kermanshah city. A total of 290 eligible patients will be selected conveniently and randomly assigned to two intervention groups.
Settings and conduct
This study, which will be conducted at Imam Reza hospital of Kermanshah city is one-blinded one so that, participants are unaware of which intervention group they will be in and when will the blood glucose be controlled?
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diabetes or impaired glucose tolerance; Lack of any malignancy
Exclusion criteria: Lack of follow-up; Migration
Intervention groups
In the first group, the blood glucose levels of patients undergoing spinal surgery during the beginning of anesthesia and during anesthesia are controlled by an anesthetist.
In the second intervention group, patients who are ready for spinal surgery from two days before surgery, during anesthesia and one day after surgery, will be under strict control of blood glucose with insulin protocol to maintain it in the range of 100 to 140 0 mg/ dec.
Main outcome variables
Infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N102
Registration date:2018-09-25, 1397/07/03
Registration timing:registered_while_recruiting
Last update:2018-09-25, 1397/07/03
Update count:0
Registration date
2018-09-25, 1397/07/03
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-11, 1397/06/20
Expected recruitment end date
2018-11-11, 1397/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of perioperative strict blood glucose control before, during and after spinal surgery (posterior approach)in elective diabetic or glucose intolerance patients on the decrease of surgical site infection
Public title
Study of the effect of strict blood glucose control before, during and after spinal surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetes or impaired glucose tolerance
Lack of any malignancy
Lack of malnutrition
Exclusion criteria:
Patients with debilitating or degenerative diseases
Lack of follow-up
Migration
Age
To 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
290
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly Individually by random number table via code receipt
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants have been blinded to which intervention group they are in
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2018-05-22, 1397/03/01
Ethics committee reference number
ir.kums.rec.1397.154
Health conditions studied
1
Description of health condition studied
lumbar traumatic fracture
ICD-10 code
S32.0
ICD-10 code description
Fracture of lumbar vertebra
Primary outcomes
1
Description
Infection
Timepoint
For one month after spinal surgery
Method of measurement
On the basis of examination, radiography and blood tilth
Secondary outcomes
empty
Intervention groups
1
Description
In the first group, the blood glucose levels of patients undergoing spinal surgery during the beginning of anesthesia and during anesthesia are controlled by an anesthetist.
Category
Treatment - Other
2
Description
In the second intervention group, patients who are ready for spinal surgery from two days before surgery, during anesthesia and one day after surgery, will be under strict control of blood glucose with insulin protocol to maintain it in the range of 100 to 140 0 mg/ dec.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Mohammadali Khodaei
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
khodaei_ali@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Mohammadali Khodaei
Position
Resident of Neurosurgery
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
khodaei_ali@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Hamidreza Saeidi
Position
Faculty Member of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 7990
Email
H-R-SAEdi@YAHOO.COM
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mohammadali Khodaei
Position
Resident Neurosurgery
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
khodaei_ali@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
Not applicable
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
6 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
In a 15-day period, the documents will be sent e-mail