The effect of preoperative fasting time on the prognosis of isolated Tibial fractures
Design
Patients are devided into Group A and B using a table of random numbers. Each group consists of 43 patients. Group B is the control group.
Settings and conduct
Each group is given fasting time instructions for them. Information on preoperative variables is asked and the required blood tests are ordered. After surgery, patients are asked about the time of the last meal eaten before surgery to be excluded from the study if it is done incorrectly. If done correctly, they will be asked for post-surgery variable information and the required blood tests will be ordered.
Participants/Inclusion and exclusion criteria
All of the patients visiting Sina and Shariati hospitals' emergency room for an isolated tibial fracture during the year 1400 who will undergo surgery will be included.
Patients who meet one the following criteria will be excluded: age below 18 and above 65 years old, not using tourniquet during the operation, pregnancy, multiple trauma, the surgery is performed after 72 hours since hospitalisation, any other concurrent fracture except for Fibular fracture, ASA score above 3
Intervention groups
We plan to change preoperative fasting time from 8 hours for both solid foods and clears liquids to 6 hours for solid foods and 2 hours for clear fluids.
Effect of Enhanced Recovery After Surgery (ERAS) protocol on isolated tibial fracture surgery’s outcome
Public title
Effect of Enhanced Recovery After Surgery (ERAS) protocol on isolated tibial fracture surgery’s outcome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients visiting Sina and Shariati hospitals' emergency room for an isolated tibial fracture during the year 1400 who will undergo surgery in the same center
Exclusion criteria:
Age below 18 years old
Age above 65 years old
Not using tourniquet during the operation
Pregnancy
Multiple trauma
The surgery is performed after 72 hours since hospitalisation
Any other concurrent fracture except for Fibular fracture
ASA score above 3
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization is performed using a table of random numbers. In this method, the table of numbers is created without any specific pattern and order, then the numbers in the first column from top to bottom are assigned to the referring patients, respectively. If the number assigned to a patient is odd, that patient enters the intervention group (group A) and if it is even, he/she enters the control group (group B). At the end, each group is given explanations and instructions related to them.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences' Sina hospital
Street address
Tehran Sina Hospital, Men's Orthopedic Department
City
Tehran
Province
Tehran
Postal code
١١٣٦٧٤٦٩١١
Approval date
2021-11-17, 1400/08/26
Ethics committee reference number
IR.TUMS.SINAHOSPITAL.REC.1400.092
Health conditions studied
1
Description of health condition studied
Tibial fracture
ICD-10 code
M84.36
ICD-10 code description
Stress fracture, tibia and fibula
Primary outcomes
1
Description
lenght of stay
Timepoint
after release from hospital
Method of measurement
days between date of surgery and date of release from hospital
Secondary outcomes
1
Description
Postoperative nausea and vomiting
Timepoint
One day after surgery
Method of measurement
Directly asking the patient
2
Description
Postoperative pain score
Timepoint
One day after surgery
Method of measurement
Visual Analogue Scale
3
Description
Blood hemoglobin level changes
Timepoint
One day after surgery
Method of measurement
Laboratory evaluation of hemoglobin level before and after surgery
4
Description
Blood creatinine changes
Timepoint
One day after surgery
Method of measurement
Laboratory evaluation of blood creatinine level before and after surgery
Intervention groups
1
Description
Intervention group: They will be instructed to stop eating and drinking all foods except clear fluids(water, light tea and coffee) 6 hours before surgery and stop drinking clear fluids 2 hours before surgery.
Category
Treatment - Other
2
Description
Control group: They will be instructed no to eat or drink any food after 00:00 a.m. the night before surgery.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Mohammad Ashouri
Street address
Imam Khomeyni st. , S Kargar
City
Tehran
Province
Tehran
Postal code
١١٣٦٧٤٦٩١١
Phone
+98 21 6312 1417
Email
mohammad.ashouri1@gmail.com
2
Recruitment center
Name of recruitment center
Shariatin hospital
Full name of responsible person
Mohammad Ashouri
Street address
Jalal Al Ahmad st., N Kargar
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 2388
Email
mohammad.ashouri1@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyed Hossein Shafiei
Street address
Imam Khomeini st. , S Kargar
City
Tehran
Province
Tehran
Postal code
١١٣٦٧٤٦٩١١
Phone
+98 21 6312 1417
Email
Dr_hshafiei@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ashouri
Position
medical student
Latest degree
A Level or less
Other areas of specialty/work
Orthopedics
Street address
Imam Khomeyni st. , S Kargar
City
Tehran
Province
Tehran
Postal code
١١٣٦٧٤٦٩١١
Phone
098 21 63121417
Email
mohammad.ashouri1@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ashouri
Position
medical student
Latest degree
A Level or less
Other areas of specialty/work
Orthopedics
Street address
Imam Khomeyni st. , S Kargar
City
Tehran
Province
Tehran
Postal code
١١٣٦٧٤٦٩١١
Phone
+98 21 6312 1417
Email
mohammad.ashouri1@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ashouri
Position
medical student
Latest degree
A Level or less
Other areas of specialty/work
Orthopedics
Street address
Imam Khomeyni st. , S Kargar
City
Tehran
Province
Tehran
Postal code
١١٣٦٧٤٦٩١١
Phone
+98 21 6312 1417
Email
mohammad.ashouri1@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available