Evaluating the effectiveness of adding oral carbohydrates to enhanced recovery after surgery (ERAS) protocol on the postoperative complications in the candidates for bariatric surgery
Determining the effectiveness of adding oral carbohydrates to enhanced recovery after surgery (ERAS) protocol on the postoperative complications in the candidates for bariatric surgery
Design
The ERAS protocol will be implemented as routine for all patients as follows:
A. Preoperative: Limit fasting to 6 hours before surgery, reduce opioid use, reduce fluid intake, prescribe anti-emetic drugs before and after surgery, maintain normal blood glucose during the protocol, avoid inserting drains.
B- Postoperative: Early oral feeding immediately after full consciousness, early mobilization of the patient to prevent ileus, administration of non-opioid analgesics and improve nutrition
C- Follow-up: Checking for complications, need for readmission
Settings and conduct
Candidates for laparoscopic gastric bariatric surgery at Sina Hospital in Tehran and Shahid Bahonar Hospital in Kerman will be included if they meet the study criteria.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Consent to participate in the study
2- Age 18 to 65 years
3- Candidate for bariatric surgery due to obesity
Exclusion criteria
1- Uncontrolled diabetes mellitus
2- Requiring further surgical intervention
3- Changing the surgical method from Laparoscopy to laparotomy
4- Unprecedented complications during the operation
Intervention groups
Intervention group: Oral 10% dextrose solution 400 cc 6 and 2 hours before surgery
Control group: no intervention
Main outcome variables
Duration of hospitalization; Presence and severity of postoperative nausea and vomiting; Electrolyte disturbances; Changes in blood glucose or serum creatinine; Severity of postoperative pain; Need to prescribe opioids during hospitalization; Wound infection; Postoperative ileus; readmission or intervention within one month.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120516009768N7
Registration date:2021-12-15, 1400/09/24
Registration timing:registered_while_recruiting
Last update:2021-12-15, 1400/09/24
Update count:0
Registration date
2021-12-15, 1400/09/24
Registrant information
Name
Akbar Shafiee
Name of organization / entity
Tehran Heart Center, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8802 9256
Email address
shafiee@leydenacademy.nl
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-11, 1400/09/20
Expected recruitment end date
2022-08-22, 1401/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effectiveness of adding oral carbohydrates to enhanced recovery after surgery (ERAS) protocol on the postoperative complications in the candidates for bariatric surgery
Public title
Evaluating the effectiveness of adding oral carbohydrates to enhanced recovery after surgery (ERAS) protocol on the postoperative complications in the candidates for bariatric surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to participate in the study
age 18-65 years
Candidate for bariatric surgery
Exclusion criteria:
Uncontrolled diabetes mellitus
Need for further surgical intervention
Change of surgical method from laparoscopy to laparotomy
Unprecedented adverse events and complications during surgery
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we use individual simple randomization using the online Research Randomizer software by producing a series of random numbers. Then the patients will be randomized into two groups by receiving a numbered sealed envelope.
Blinding (investigator's opinion)
Single blinded
Blinding description
The surgeon and the surgical team are not aware of the patient's group and are blinded to it.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Afzalipour Hospital- Kerman University of Medical Sciences
Street address
Afzalipour Hospital, Besides Kerman University of Medical Sciences, Imam Khomeini Blvd, Kerman
City
Kerman
Province
Kerman
Postal code
7616913355
Approval date
2021-10-09, 1400/07/17
Ethics committee reference number
IR.KMU.AH.REC.1400.146
Health conditions studied
1
Description of health condition studied
Morbid Obesity
ICD-10 code
E66.01
ICD-10 code description
Morbid (severe) obesity due to excess calories
2
Description of health condition studied
Bariatric surgery
ICD-10 code
Z98.84
ICD-10 code description
Bariatric surgery status
Primary outcomes
1
Description
Duration of hospitalization
Timepoint
Hospital admission
Method of measurement
Patient's file
2
Description
Postoperative pain
Timepoint
during admission
Method of measurement
VAS score
3
Description
postoperative nausea and vomiting
Timepoint
During admission
Method of measurement
Questionnaire
4
Description
Surgical wound infection
Timepoint
During admission up to 1 months after surgery
Method of measurement
History and physical examination
5
Description
readmission or reoperation
Timepoint
Up to 1 month after surgery
Method of measurement
Follow-up and observation
6
Description
Administration of analgesic or opioid
Timepoint
During hospital admission
Method of measurement
Patient's file
Secondary outcomes
1
Description
Changes in blood glucose
Timepoint
During admission
Method of measurement
Lab test
2
Description
Changes in serum creatinine
Timepoint
During admission
Method of measurement
Lab test
3
Description
postoperative ileus
Timepoint
During admission
Method of measurement
Patient's file
Intervention groups
1
Description
Intervention group: [Oral administration of 400 cc dextrose 20% solution 8 hours before the operation and another 200 cc 2 hours before the operation. We will use commercially available dextrose 20% vials in this study.
Category
Treatment - Other
2
Description
Control group: Routine care with no intervention or placebo
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Mitra Manavi
Street address
Imam Khomeini ave,
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Email
mitramanavi72@gmail.com
2
Recruitment center
Name of recruitment center
Afzalipour hospital
Full name of responsible person
Alireza Amirbeigi
Street address
Afzalipour hospital, Imamkhomeni Blvd, Kerman
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Email
Ali_amirbeigi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Khosro Najjari
Street address
Sina Hospital, Imam Khomeini Ave.
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Email
Knajjari@tums.ac.ir
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
Mitra Manavi
Position
Fellowship
Latest degree
Subspecialist
Other areas of specialty/work
Laparoscopic surgery
Street address
Sina Hospital, Imam Khomeini Ave.
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Email
mitramanavi72@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mitra Manavi
Position
Fellowship
Latest degree
Subspecialist
Other areas of specialty/work
Laparoscopic surgery
Street address
Sina Hospital, Imam Khomeni Ave.
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
0982166348500
Email
mitramanavi72@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Shafiee
Position
Research Associate
Latest degree
Specialist
Other areas of specialty/work
Community medicine
Street address
North Kargar Ave
City
Tehran
Province
Tehran
Postal code
1411713138
Phone
+98 21 8802 9256
Fax
+98 21 8802 9731
Email
ashafiee@tums.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
Study data will be published anonymously and completely in the form of an article.
When the data will become available and for how long
Available as soon as publication of the results
To whom data/document is available
researchers and physicians
Under which criteria data/document could be used
decision upon request
From where data/document is obtainable
Dr. Mitra Manavi mitramanavi72@gmail.com
What processes are involved for a request to access data/document