Evaluation of the effects of preoperative carbohydrate loading on inflammatory factors and postoperative complications
Design
Participants are then randomly divided into two treatment groups. One of the two groups is fasting as standard before surgery with a normal duration and the other group is undergoing glucose loading as follows. From surgery and then a solution of 400 cc is consumed 2 to 4 hours before surgery. Then albumin, crp, the ratio of the two to each other, as well as the amount of pain and the use of analgesics in 6 hours after surgery, and the same hours the next day and two days after surgery will be measured.
Settings and conduct
Sampling will be done randomly from the study population, which includes inclusion criteria and no exclusion criteria. Sample volume was considered with 95% confidence interval, 0.05 error coefficient and 80% power using Cochran's sample size determination formula
Participants/Inclusion and exclusion criteria
Inclusion criteria include: . Elective case of laparoscopic cholecystectomy . Age over 18 years . Age less than 70 years . Ability to understand and speak in Persian
Exclusion criteria: . History of metabolic diseases such as diabetes . Body mass index below 20 and above 30 . Any disorder requires emergency surgical intervention . Dissatisfaction with the study
Intervention groups
Intervention group: Medical candidate for elective surgery by npo to two hours
Control group: elective surgery information with a npo eight hours
Main outcome variables
Effects of glucose loading on plasma levels of inflammatory factors after surgery (including albumin, CRP to plasma albumin ratio) Prevalence of leakage from surgical drainage in patients who received glucose loading before surgery. Prevalence of wound complications (including wound opening, wound infection) Evaluation of drainage output in patients with preoperative glucose loading The effect
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200629047952N1
Registration date:2021-06-04, 1400/03/14
Registration timing:registered_while_recruiting
Last update:2021-06-04, 1400/03/14
Update count:0
Registration date
2021-06-04, 1400/03/14
Registrant information
Name
Ehsan Beigi shahr-e babak
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3670 3862
Email address
ehsanbeigi87@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-05, 1400/02/15
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
effect of preoperative oral carbohydrate loading on laparoscopic outcome and metabolic respons
Public title
Effect of preoperative oral carbohydrt loading
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age upper18 ,under 70 years
Elective surgery cholelitiasis laparoscopy
Persian language
Exclusion criteria:
Pregnancy
Emergen and urgent surgery
Acute and chronic cholecystit
Bmi less of 20 and more than 30
Metabolic syndrom
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Use a random number table for verification. Direction Use Random Number Table Start reading the set table numbers The numbers will then be considered for different groups Be. Lay on one of the numbers and in one direction in advance Moves are assigned and assigned numbers to different feature groups I was doing
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be blinded in two ways. Patients according to type The intervention is blinded as well as the researcher who must enter the data into the checklist Relevant will be blinded to the type of intervention
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethcs committee of alborz university of medical sciences
Street address
Taleghani sq. Alborz uineversity
City
Karaj
Province
Alborz
Postal code
3183966918
Approval date
2021-05-02, 1400/02/12
Ethics committee reference number
IR.ABZUMS.REC.1400.035
Health conditions studied
1
Description of health condition studied
Npo time
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain.
Timepoint
۰،۶،۱۲،۲۴،(houres), 3,7 dayes
Method of measurement
Vas, cc,need to analtgic
2
Description
Leakage of drain
Timepoint
O,6,12,24,48 hours
Method of measurement
Mililiter
3
Description
Vomiting
Timepoint
6,12,24 ,48 hours
Method of measurement
Need to ondansetron
4
Description
Crp
Timepoint
Day 1 and day 2 at 8 am
Method of measurement
Mg
5
Description
Albumin
Timepoint
Day 1 day 2 at 8 am
Method of measurement
Mg
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group is loaded with glucose as follows, first 12.5% solution at a rate of 800 cc in the evening before surgery and then a solution at a rate of 400 cc 2 to 4 hours before surgery.Then albumin, crp, the ratio of the two to each other, as well as the amount of pain and the use of analgesics in 6 hours after surgery, and the same hours the next day and two days after surgery will be measured. Finally, the collected data will be analyzed and compared
Category
Rehabilitation
2
Description
Control group :Control group: 400 cc of water is given to the patient 2 clocks before the operation, if desired. Water was given with aspartame sugar, which is a sweet solution and has zero calories. After that, the operation of the variables is checked and completed
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam ali hospital
Full name of responsible person
Mehdi tavalaee
Street address
Azimiyeh.emam ali hospital
City
Karaj
Province
Alborz
Postal code
۱۱۱۱۱۱۱۱۱
Phone
+98 26 3670 5593
Email
Ehsanbeigi87@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Noori sepehr mohamad
Street address
Azimiye .emam ali hospital
City
Karaj
Province
Alborz
Postal code
۱۱۱۱۱۱۱۱
Phone
+98 26 3670 5593
Email
Ehsanbeigi87@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj 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
Karaj University of Medical Sciences
Full name of responsible person
Mehdi tavalaee
Position
Associtat professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Azimiyeh, emam ali hospital
City
Karaj
Province
Alborz
Postal code
۱۱۱۱۱۱۱۱۱
Phone
+98 26 3670 5593
Email
Ehsanbeigi87@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Mehdi tavalaer
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Azimiye, emam ali hospital
City
Karaj
Province
Alborz
Postal code
۱۱۱۱۱۱۱۱
Phone
+98 26 3670 5593
Email
Ehsanbeigi87@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Mehdi tavalaer
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Azimiyeh, emam ali hospital
City
Karaj
Province
Alborz
Postal code
۱۱۱۱۱۱۱۱
Phone
+98 26 3670 3862
Email
Ehsanbeigi87@gmail.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
Clinical information on the effects of loading. Carbohydrates on reducing postoperative complications will be fully shared and laboratory and demographic data will be shared
When the data will become available and for how long
۲۰۲۱
To whom data/document is available
Universities and scientific authorities of the iran
Under which criteria data/document could be used
Scientific
From where data/document is obtainable
Alborz University of Medical Sciences Research Assistant Karaj. Taleghani Square Research Deputy Postal Code 3183966987 Phone 02634287335
What processes are involved for a request to access data/document
Competent and enthusiastic researchers can document data after publication Work of the responsible author by providing academic information and self-identification .To receive