Evaluation and comparison of short-term effects of surgery in patients receiving intensive care and patients receiving care with conventional methods in mini omega bariatric surgery
Evaluation and comparison of short-term effects of surgery in patients receiving intensive care and patients receiving care with conventional methods in mini omega bariatric surgery
Design
Clinical trial with control group with parallel groups, phase 2 on 110 patients
Settings and conduct
This study is performed in Al-Zahra Hospital in Isfahan. Patients will be cared for in two ways, comparing the complications of surgery and nausea with vomiting and the length of hospital stay.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age over 18 years, candidate for mini omega bariatric surgery, patients' consent to enter the study
Exclusion criteria: location of the patient away from the hospital, lack of patient cooperation
Intervention groups
Intervention group 1: Patients in this group will be treated with intensive care protocol. If a nurse is assigned to each patient, the patient will fast on the day of admission, will receive 1 gram of oral paracetamol before admission, will receive 2 grams of cefazolin or 600 mg of clindamycin, and will be treated with dexamethasone and ondansetron. And no drans will be used for him. Complications of the operation, duration of hospitalization, and nausea and vomiting in the patient will be measured and evaluated.
Intervention group 2: Patients in this group will be treated according to the standard care protocol in the hospital. Complications of the operation, duration of hospitalization, and nausea and vomiting in the patient will be measured and evaluated.
Main outcome variables
Complications of surgery and vomiting and duration of hospitalization
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210614051574N6
Registration date:2021-12-21, 1400/09/30
Registration timing:prospective
Last update:2021-12-21, 1400/09/30
Update count:0
Registration date
2021-12-21, 1400/09/30
Registrant information
Name
Ghasem Mohammadsharifi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3729 4005
Email address
mohammadsharifi.ghasem@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-04, 1400/10/14
Expected recruitment end date
2022-02-03, 1400/11/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and comparison of short-term effects of surgery in patients receiving intensive care and patients receiving care with conventional methods in mini omega bariatric surgery
Public title
Intensive care in mini omega bariatric surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Candidate for mini omega bariatric surgery
Patient consent to enter the study
Exclusion criteria:
Location of the patient away from the hospital
Patient non-cooperation
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
55
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Esfahan University of Medical Sciences
Street address
Esfahan University of Medical Sciences, Hezar Jarib Ave., Esfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-09-28, 1400/07/06
Ethics committee reference number
IR.MUI.MED.REC.1400.530
Health conditions studied
1
Description of health condition studied
Obesity
ICD-10 code
E66
ICD-10 code description
Overweight and obesity
Primary outcomes
1
Description
Complications of the operation
Timepoint
The day after discharge and 1 month after surgery
Method of measurement
Asking patients and reviewing records
2
Description
Duration of hospitalization
Timepoint
The day after discharge
Method of measurement
File review
3
Description
nausea and vomiting
Timepoint
The day after discharge and 1 month after surgery
Method of measurement
Asking patients and reviewing records
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Patients in this group will be treated with intensive care protocol. If a nurse is assigned to each patient, the patient will fast on the day of admission, will receive 1 gram of oral paracetamol before admission, will receive 2 grams of cefazolin or 600 mg of clindamycin, and will be treated with dexamethasone and ondansetron. And no drans will be used for him. Complications of the operation, duration of hospitalization, and nausea and vomiting in the patient will be measured and evaluated.
Category
Treatment - Other
2
Description
Intervention group 2: Patients in this group will be treated according to the standard care protocol in the hospital. Complications of the operation, duration of hospitalization, and nausea and vomiting in the patient will be measured and evaluated.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra hospital
Full name of responsible person
Mohsen Mahmoodieh
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
parsa.alinezhad85@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave,. Daneshgah Blvd, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673118
Phone
+98 31 3668 0048
Email
haghjoo.sh@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mohsen Mahmoodieh
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
parsa.alinezhad85@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohsen Mahmoodieh
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
parsa.alinezhad85@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohsen Mahmoodieh
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
parsa.alinezhad85@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
All data can be shared after people have requested.
When the data will become available and for how long
Six months after publishing the results.
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Scientific uses
From where data/document is obtainable
Website of the Research Committee of Isfahan University of Medical Sciences
What processes are involved for a request to access data/document
Clear request on the site to access the data by the individual and then review the request by the research assistant within 2 weeks and then allow access to the data.