Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000162617
Ethics application status
Approved
Date submitted
19/01/2023
Date registered
17/02/2023
Date last updated
19/10/2023
Date data sharing statement initially provided
17/02/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Systemic inflammation in bariatric surgery
Scientific title
Investigation of the Effect of Obesity Surgery on Inflammatory Markers and Its Relationship with Smoking.
Secondary ID [1] 308914 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 327647 0
Bariatric surgery 327648 0
Condition category
Condition code
Inflammatory and Immune System 324735 324735 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The study was planned as a single-center, controlled and retrospective study. Data obtained from preoperative and postoperative laboratory records of patients who underwent bariatric surgery in Karaman Training and Research Hospital between May 2021 and November 2022 will be evaluated. The parameters planned to be evaluated are SII (NeutrophilxPlatenet/Lymphocyte), Neutrophil/Lymphocyte ratio (N/L), Platelet/Lymphocyte ratio (T/L) based on Neutrophil (N), lymphocyte (L) and platelet (P) counts. The data will be accessed from the electronic database of our hospital. The record to be examined before the operation; the 1-week period before the operation, the record to be examined after the operation; The patient will have hemogram parameters evaluated at the first month and after the operation to the surgical outpatient clinic for control purposes.
Intervention code [1] 325066 0
Diagnosis / Prognosis
Comparator / control treatment
Potential confounders such as smoking, obstructive sleep apnea, and gender may affect the interaction between different inflammatory markers. For this reason, we plan to test with a non-smoker and non-comorbid, operated and followed control group.
Control group
Active

Outcomes
Primary outcome [1] 333378 0
Systemic inflammation assessed by blood samples - biomarkers SII (NeutrophilxPlatenet/Lymphocyte) based on neutrophil (N), lymphocyte (L) and platelet (P) counts, Neutrophil/Lymphocyte ratio(N/L), Platelet/Lymphocyte ratio(T/L).
Timepoint [1] 333378 0
Postoperative 1th month and 3th month
Secondary outcome [1] 416848 0
nil
Timepoint [1] 416848 0
nil

Eligibility
Key inclusion criteria
Patients over 18 years of age with a diagnosis of morbid obesity who underwent bariatric surgery will be included in the study.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those who are illiterate in Turkish, those with active psychiatric disorders and those who do not give consent will be excluded from the study.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Case control
Timing
Retrospective
Statistical methods / analysis
anova

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
15/12/2022
Date of last participant enrolment
Anticipated
Actual
1/02/2023
Date of last data collection
Anticipated
30/12/2023
Actual
Sample size
Target
60
Accrual to date
Final
80
Recruitment outside Australia
Country [1] 25179 0
Turkey
State/province [1] 25179 0
Karaman

Funding & Sponsors
Funding source category [1] 312249 0
Hospital
Name [1] 312249 0
Karaman education and research hospital
Country [1] 312249 0
Turkey
Primary sponsor type
Hospital
Name
Karaman education and research hospital
Address
Karaman education and research hospital University Mh., 1984. Sok. No:1, 70200 Merkez/Karaman
Country
Turkey
Secondary sponsor category [1] 314513 0
None
Name [1] 314513 0
none
Address [1] 314513 0
none
Country [1] 314513 0
Other collaborator category [1] 282507 0
Individual
Name [1] 282507 0
SÜKRÜ SALIH TOPRAK
Address [1] 282507 0
Karaman education and research hospital University Mh., 1984. Sok. No:1, 70200 Merkez/Karaman.
Country [1] 282507 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311624 0
Karamanoglu Mehmetbey Üniversity Medicine Fakulty Etihics Committee
Ethics committee address [1] 311624 0
University, 70200 Karaman Merkez/Karaman
Ethics committee country [1] 311624 0
Turkey
Date submitted for ethics approval [1] 311624 0
10/10/2022
Approval date [1] 311624 0
08/11/2022
Ethics approval number [1] 311624 0
10-2022/08

Summary
Brief summary
Obesity can be considered as a widespread pandemic of today. Bariatric surgery is the treatment method for the surgical treatment of morbid obesity. Neutrophil/Lymphocyte ratio (N/L), Platelet/Lymphocyte ratio (T/L) and Systemic Immune Inflammatory Index (Siii) are important inflammatory markers. There are many studies in the literature with the contribution of obesity on inflammatory markers. It was planned to be used as an SII (NeutrophilxPlatenet/Lymphocyte) biomarker based on neutrophil (N), lymphocyte (L) and platelet (P) counts. In the hypothesis that we established in our study, it was accepted that inflammation decreased in the post-bariatric surgery period. . Potential confounders such as smoking, obstructive sleep apnea, and gender may affect the interaction between different inflammatory markers. For this reason, we are planning to test with a control group that does not smoke and does not have any comorbidities, who were operated and followed up.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121762 0
Dr Hatice Toprak
Address 121762 0
Karaman Education and Research Hospital. Üniversity mah. 1984. sok. merkez/Karaman
Country 121762 0
Turkey
Phone 121762 0
+903382263000
Fax 121762 0
Email 121762 0
[email protected]
Contact person for public queries
Name 121763 0
Hatice Toprak
Address 121763 0
Karaman Education and Research Hospital. Üniversity mah. 1984. sok. merkez/Karaman
Country 121763 0
Turkey
Phone 121763 0
+903382263000
Fax 121763 0
Email 121763 0
[email protected]
Contact person for scientific queries
Name 121764 0
Hatice Toprak
Address 121764 0
Karaman Education and Research Hospital. Üniversity mah. 1984. sok. merkez/Karaman
Country 121764 0
Turkey
Phone 121764 0
+903382260000
Fax 121764 0
Email 121764 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.