Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000051640
Ethics application status
Approved
Date submitted
25/11/2022
Date registered
17/01/2023
Date last updated
17/01/2023
Date data sharing statement initially provided
17/01/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of preoperative polyunsaturated fatty acid use on perioperative inflammatory response
Scientific title
The effect of preoperative polyunsaturated fatty acid use on perioperative inflammatory response in women undergoing caesarean section
Secondary ID [1] 308498 0
none
Universal Trial Number (UTN)
Trial acronym
PIPFA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
perioperative inflammatory response 328307 0
postoperative pain 328308 0
Condition category
Condition code
Anaesthesiology 325355 325355 0 0
Other anaesthesiology
Inflammatory and Immune System 325484 325484 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
omega-3 polyunsaturated fatty acid (PUFA);
- the dose administered, 500 mg once daily;
- the duration of administration, 3 mounths;
- the mode of administration, oral tablet.
all data will be directly collected from medical records
duration described will have the following data collected intraoperatively and over the duration of 24 ours of their hospital stay.
demographic information (age, gender, weight, BMI, gestational age, known diseases and medications used during pregnancy)
inflammation biomarkers in serum (c-reactive protein, interleukin-6, interleukin-10),
intraoperative monitoring(hemodynamic datas, operation time, bleeding)
Intervention code [1] 324930 0
Diagnosis / Prognosis
Comparator / control treatment
omega-3 pufa non-users
Control group
Active

Outcomes
Primary outcome [1] 333212 0
perioperative inflammatory response assessed by interleukin-6 levels in serum
Timepoint [1] 333212 0
1 hour before the operation,
6 hours after the operation,
24 hours after the operation.
Primary outcome [2] 333425 0
perioperative inflammatory response assessed by interleukin-10 levels in serum
Timepoint [2] 333425 0
1 hour before the operation,
6 hours after the operation,
24 hours after the operation.
Primary outcome [3] 333426 0
perioperative inflammatory response assessed by C-reaktive protein levels in serum
Timepoint [3] 333426 0
1 hour before the operation,
6 hours after the operation,
24 hours after the operation.
Secondary outcome [1] 416186 0
postoperative pain assessed numeric rating score
Timepoint [1] 416186 0
postoperative period 6 ours after the operation and 24 ours after the operation.
Secondary outcome [2] 417035 0
hospital stay duration
Timepoint [2] 417035 0
postoperative period at stay hospital

Eligibility
Key inclusion criteria
Between 1 November 2022 and 31 January 2023,
physical status is ASA II according to the classification of the American Society of Anesthesiology (ASA),
over 18 years,
using fish oil supplement with at least 500 mg of omega3 content,
omega-3 pufa users (for the omega-3 group)
omega-3 pufa non-users (for the control group)
Minimum age
18 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with poor orientation and cooperation,
serious psychiatric patients
emergency cases,
gestational diabetes,
gestational hypertension,
preeclampsia,
eclampsia,
patients with a history of cardiac arrhythmia and heart failure,
Patients using fish oil supplement preparation with less than 500 mg or higher omega3 content,
patients with chronic smoking, alcohol or drug addiction
patients who do not agree to volunteer

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis
SPSS program will be used for statistical analysis. Descriptive values will be expressed as mean±standard deviation. Chi-Square Test will be used for ASA score and gender assessments. The Kolmogorov-Smirnov Test will be used for the evaluation of all data about the groups. It was planned to evaluate the compatible data with the Student T Test and the inconsistent data with the Mann Witney U Test.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
8/12/2022
Date of last participant enrolment
Anticipated
31/03/2023
Actual
Date of last data collection
Anticipated
1/04/2023
Actual
Sample size
Target
30
Accrual to date
7
Final
Recruitment outside Australia
Country [1] 25157 0
Turkey
State/province [1] 25157 0
Konya

Funding & Sponsors
Funding source category [1] 312740 0
University
Name [1] 312740 0
T.R. Necmettin Erbakan University Scientific Research Projects Coordinatorship
Country [1] 312740 0
Turkey
Primary sponsor type
University
Name
T.R. Necmettin Erbakan University Scientific Research Projects Coordinatorship
Address
Necmettin Erbakan Üniversitesi Meram Tip Fakültesi Morfoloji Ek Binasi 2. Kat

Bilimsel Arastirma Projeleri Koordinatörlügü Akyokus / Meram / KONYA
Country
Turkey
Secondary sponsor category [1] 314361 0
None
Name [1] 314361 0
Address [1] 314361 0
Country [1] 314361 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312035 0
N.E.Ü. Meram Tip Fakültesi Klinik Arastirmalar Etik Kurulu
Ethics committee address [1] 312035 0
Necmettin Erbakan Üniversitesi Meram Tip Fakültesi Morfoloji Ek Binasi 2. Kat

Etik Kurullar

Akyokus / Meram / KONYA
Ethics committee country [1] 312035 0
Turkey
Date submitted for ethics approval [1] 312035 0
Approval date [1] 312035 0
23/02/2022
Ethics approval number [1] 312035 0

Summary
Brief summary
Inflammatory process; Secretion of anti-inflammatory cytokines can be regulated by negative feedback mechanisms, including inhibition of proinflammatory signals and loss of receptors to which inflammatory mediators will bind. The association of polyunsaturated fatty acids with inflammation is mediated by the production of eicosanoids. Eicosanoid synthesis occurs through polyunsaturated fatty acids obtained from phospholipids in the cell membrane by the phospholipase A2 enzyme. While there are studies on the use of polyunsaturated fatty acids in different patient groups in the literature, studies on the perioperative period are limited. With this study, it is aimed to show the effects of perioperative omega3-6 fatty acid use.
In this study, pregnant women who were planned to deliver by cesarean section under elective conditions, between 1 April 2022 and 31 December 2022, whose physical status is ASA II according to the American Society of Anesthesiology (ASA) classification, over 18 years of age, omega3 and omega6 content of at least 500 mg in total will be included. 30 patients using fish oil supplements will be included. Demographic information of the patients (age, gender, weight, BMI, gestational age, known diseases and medications used during pregnancy) will be recorded. Interleukin-6 and Interleukin-10 serum levels will be studied in the laboratory environment in 3 different time periods, preoperative, postoperative 6th hour and postoperative 24th hour.
group omega; Patients who use nutritional supplements containing omega-3 and omega-6 and continue to use them for at least 8 weeks before the operation,
group control; It consists of patients who have not used any omega3 and omega6 nutritional supplements for at least 8 weeks.
The patients in both groups will undergo the normal surgical procedure.
SPSS program will be used for statistical analysis. Descriptive values will be expressed as mean±standard deviation. Chi-Square Test will be used for ASA score and gender assessments. The Kolmogorov-Smirnov Test will be used for the evaluation of all data about the groups. It was planned to evaluate the compatible data with the Student T Test and the inconsistent data with the Mann Witney U Test
Trial website
Trial related presentations / publications
Public notes
none

Contacts
Principal investigator
Name 123258 0
Dr RESUL YILMAZ
Address 123258 0
Necmettin Erbakan Univercity Meram Faculty Of Medicine, Hocacihan Mah. Abdulhamid Han Cad. No:3 PK: 42080 Selçuklu/KONYA (Yeni Hastane)
KONYA
Country 123258 0
Turkey
Phone 123258 0
+903322234042
Fax 123258 0
+90 332 223 60 00
Email 123258 0
dr.r.yilmaz@gmail.com
Contact person for public queries
Name 123259 0
Dr RESUL YILMAZ
Address 123259 0
Necmettin Erbakan Univercity Meram Faculty Of Medicine, Hocacihan Mah. Abdulhamid Han Cad. No:3 PK: 42080 Selçuklu/KONYA (Yeni Hastane)
KONYA
Country 123259 0
Turkey
Phone 123259 0
+903322234042
Fax 123259 0
+90 332 223 60 00
Email 123259 0
dr.r.yilmaz@gmail.com
Contact person for scientific queries
Name 123260 0
Dr RESUL YILMAZ
Address 123260 0
Necmettin Erbakan Univercity Meram Faculty Of Medicine, Hocacihan Mah. Abdulhamid Han Cad. No:3 PK: 42080 Selçuklu/KONYA (Yeni Hastane)
KONYA
Country 123260 0
Turkey
Phone 123260 0
+903322234042
Fax 123260 0
Email 123260 0
dr.r.yilmaz@gmail.com

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.