Inflammatory ResponseNCT06345313
The Effects of Surgery Performed At Different Times of the Day on Inflammation and Recovery
A study testing Day Group and Night Group in people with Inflammatory Response, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
To evaluate the inflammatory response of participants who will undergo unilateral inguinal hernia surgery at two different times of the day (08.00-12.00 during the day and 18.00-22.00 at night). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Response
- What is being tested?
- Day Group and Night Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2024to 15 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA (American society of anesthesiologists) 1-2 adult participants between the ages of 18-70 who will undergo unilateral inguinal herniorrhaphy surgery at the Republic of Turkey Ministry of Health Ankara City Hospital.
Who cannot join
- Do not want to participate in the study
- Younger than 18 or older than 70
- Scores 6 and above on the preoperative Athens Insomnia Scale.
- ASA (American society of anesthesiologists) scores of 3 or greater than 3
- Have contraindications to the use of anesthetic drugs
- BMI>30 kg/m^2
Show all 12Show fewer
- Have bilateral herniorrhaphy surgery
- Complicated inguinal hernia (incarcerated, strangulated…)
- Pregnancy
- Emergency surgeries
- Laparoscopic surgeries
- Develop an unexpected intraoperative surgical complication
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Ankara, CANKAYA, 06800
About this study
To evaluate the inflammatory response of participants who will undergo unilateral inguinal hernia surgery at two different times of the day (08.00-12.00 during the day and 18.00-22.00 at night). The main question it aims to answer is; Is the inflammation response higher in participants who undergo surgery later in the day? Serum inflammatory parameters will be measured in both groups at the preoperative 1st hour and the postoperative 24th hour.
Read the detailed description
Participants who would undergo unilateral inguinal herniography surgery at different times during the day were determined into two groups: day (08.00-12.00) and night (18.00-22.00). The Athens Insomnia Scale (AIS) will be asked verbally on the first preoperative day to determine the participants' preoperative circadian rhythm adaptation and sleep status. Serum inflammatory parameters of both participant groups will be measured and recorded at the preoperative 1st hour and the postoperative 24th hour. A laryngeal mask will be applied to the participants after induction with 2-3 mg/kg propofol and 1mg/kg fentanyl, as in routine anesthesia practice. Anesthesia maintenance will be provided with sevoflurane and 0.05-0.2 mcg/kg/min remifentanil infusion. Participants' age, gender, weight, height, BMI (body mass index), comorbidities, medications used, surgeries, ASA (American society of anesthesiologists) scoring, preoperative AIS (Athens insomnia scale) score, and preoperative laboratory data will be recorded. At the same time, participants' postoperative hospital stay, resting and moving NRS (Numeric rating scale) scores at the 24th postoperative hour, and recovery quality (Qor-15 score) from anesthesia will be recorded.
- Conditions
- Inflammatory Response
- Being tested
- Day Group, Night Group
- Keywords
- CIRCADIAN RHYTHM, POSTOPERATİVE RECOVERY
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Day GroupProcedure or surgery
Patient group that will be operated on between 08.00-12.00
Night GroupProcedure or surgery
Patient group that will be operated on between 18.00-22.00
| Study group | Role | What they receive |
|---|---|---|
| Day Group | Active comparator | Participants who underwent inguinal herniography operation between 08.00-12.00 Receives: Procedure: Day Group |
| Night Group | Active comparator | Participants who underwent inguinal herniography operation between 18.00-22.00 Receives: Procedure: Night Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of IL6 (interleukin6) (ng/ml)
IL6 (one of the inflammatory parameters, compared to baseline according to circadian rhythm) is a validated parameter that shows the severity of inflammation and trauma that can be measured in serum. Change = (postoperative 24th hour - preoperative 1st hour) higher difference means more inflammatory response.
Measured: Postoperative 24th hour
Secondary outcomes (9)
Quality of recovery from anesthesia according to difference in circadian rhythm
The quality of recovery-15 (QoR-15) is a patient-reported outcome measurement measuring QoR after surgery and anesthesia. The scale is arbitrary and ranges from 0 to 150. Higher results mean better build quality.
Measured: Postoperative 24th hour
Change of NLR ( Neutrophil/ Lymphocyte Ratio )
NLR (one of the inflammatory parameters, compared to baseline according to circadian rhythm) is a validated parameter that shows the severity of inflammation that can be measured in serum. Change = (postoperative 24th hour - preoperative 1st hour) higher difference means more inflammatory response.
Measured: Postoperative 24th hour
Change of PLR ( Platelet / Lymphocyte Ratio )
PLR (one of the inflammatory parameters, compared to baseline according to circadian rhythm) is a validated parameter that shows the severity of inflammation that can be measured in serum. Change = (postoperative 24th hour - preoperative 1st hour) higher difference means more inflammatory response.
Measured: Postoperative 24th hour
Change of SII (Systemic immune-inflammation index )
SII (Neutrophil × Platelet/ Lymphocyte) (one of the inflammatory parameters, compared to baseline according to circadian rhythm) is a validated parameter that shows the severity of inflammation that can be measured in serum. Change = (postoperative 24th hour - preoperative 1st hour) higher difference means more inflammatory response.
Measured: Postoperative 24th hour
Change of CRP (C Reactive Protein) (mg/dl)
CRP (one of the inflammatory parameters, compared to baseline according to circadian rhythm) is a validated parameter that shows the severity of inflammation that can be measured in serum. Change = (postoperative 24th hour - preoperative 1st hour) higher difference means more inflammatory response.
Measured: Postoperative 24th hour
Change of Fibrinogen (mg)
Fibrinogen (one of the inflammatory parameters, compared to baseline according to circadian rhythm) is a validated parameter that shows the severity of inflammation that can be measured in serum. Change = (postoperative 24th hour - preoperative 1st hour) higher difference means more inflammatory response.
Measured: Postoperative 24th hour
Change of Sedimentation (mm/hour)
Sedimentation (one of the inflammatory parameters, compared to baseline according to circadian rhythm) is a validated parameter that shows the severity of inflammation that can be measured in serum. Change = (postoperative 24th hour - preoperative 1st hour) higher difference means more inflammatory response.
Measured: Postoperative 24th hour
Change of Procalcitonin (µg/l)
Procalcitonin (one of the inflammatory parameters, compared to baseline according to circadian rhythm) is a validated parameter that shows the severity of inflammation that can be measured in serum. Change = (postoperative 24th hour - preoperative 1st hour) higher difference means more inflammatory response.
Measured: Postoperative 24th hour
Change of Ferritin (ml/ng)
Ferritin (one of the inflammatory parameters, compared to baseline according to circadian rhythm) is a validated parameter that shows the severity of inflammation that can be measured in serum. Change = (postoperative 24th hour - preoperative 1st hour) higher difference means more inflammatory response.
Measured: Postoperative 24th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start15 Apr 2024
- Primary completion15 Oct 2024
- Study completion15 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory ResponseStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06345313
- Sponsor's protocol ID
- Inflammation
- Status last verified
- Mar 2025
- First submitted
- 27 Mar 2024
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dikmen Demiryorgan B, Nalbant B, Demiryorgan F, Kavak Akelma F. The effect of unilateral inguinal hernia surgery performed at different times of the day on inflammation and recovery: a prospective randomized controlled study. Updates Surg. 2026 May 19. doi: 10.1007/s13304-026-02669-9. Online ahead of print.
PubMed 42154167
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Surgery Performed At Different Times of the Day on Inflammation and Recovery
- ClinicalTrials.gov ID
- NCT06345313
- Acronym / sponsor ID
- Inflammation
- Conditions
- Inflammatory Response
- Keywords
- CIRCADIAN RHYTHM, POSTOPERATİVE RECOVERY
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 3 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the inflammatory response of participants who will undergo unilateral inguinal hernia surgery at two different times of the day (08.00-12.00 during the day and 18.00-22.00 at night). The main question it aims to answer is; Is the inflammation response higher in participants who undergo surgery later in the day? Serum inflammatory parameters will be measured in both groups at the preoperative 1st hour and the postoperative 24th hour.
Detailed description
Participants who would undergo unilateral inguinal herniography surgery at different times during the day were determined into two groups: day (08.00-12.00) and night (18.00-22.00). The Athens Insomnia Scale (AIS) will be asked verbally on the first preoperative day to determine the participants' preoperative circadian rhythm adaptation and sleep status. Serum inflammatory parameters of both participant groups will be measured and recorded at the preoperative 1st hour and the postoperative 24th hour. A laryngeal mask will be applied to the participants after induction with 2-3 mg/kg propofol and 1mg/kg fentanyl, as in routine anesthesia practice. Anesthesia maintenance will be provided with sevoflurane and 0.05-0.2 mcg/kg/min remifentanil infusion. Participants' age, gender, weight, height, BMI (body mass index), comorbidities, medications used, surgeries, ASA (American society of anesthesiologists) scoring, preoperative AIS (Athens insomnia scale) score, and preoperative laboratory data will be recorded. At the same time, participants' postoperative hospital stay, resting and moving NRS (Numeric rating scale) scores at the 24th postoperative hour, and recovery quality (Qor-15 score) from anesthesia will be recorded.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Day Group | Active comparator | Procedure: Day GroupParticipants who underwent inguinal herniography operation between 08.00-12.00 |
| Night Group | Active comparator | Procedure: Night GroupParticipants who underwent inguinal herniography operation between 18.00-22.00 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA (American society of anesthesiologists) 1-2 adult participants between the ages of 18-70 who will undergo unilateral inguinal herniorrhaphy surgery at the Republic of Turkey Ministry of Health Ankara City Hospital.
Key exclusion criteria (12 listed)
- Do not want to participate in the study
- Younger than 18 or older than 70
- Scores 6 and above on the preoperative Athens Insomnia Scale.
- ASA (American society of anesthesiologists) scores of 3 or greater than 3
- Have contraindications to the use of anesthetic drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Day GroupPatient group that will be operated on between 08.00-12.00 | Procedure or surgery | Day Group |
| Night GroupPatient group that will be operated on between 18.00-22.00 | Procedure or surgery | Night Group |
Primary outcome
Change of IL6 (interleukin6) (ng/ml)
Time frame: Postoperative 24th hour
IL6 (one of the inflammatory parameters, compared to baseline according to circadian rhythm) is a validated parameter that shows the severity of inflammation and trauma that can be measured in serum. Change = (postoperative 24th hour - preoperative 1st hour) higher difference means more inflammatory response.
9 secondary outcomes
Quality of recovery from anesthesia according to difference in circadian rhythm
Time frame: Postoperative 24th hour
Change of NLR ( Neutrophil/ Lymphocyte Ratio )
Time frame: Postoperative 24th hour
Change of PLR ( Platelet / Lymphocyte Ratio )
Time frame: Postoperative 24th hour
Change of SII (Systemic immune-inflammation index )
Time frame: Postoperative 24th hour
Change of CRP (C Reactive Protein) (mg/dl)
Time frame: Postoperative 24th hour
Change of Fibrinogen (mg)
Time frame: Postoperative 24th hour
Change of Sedimentation (mm/hour)
Time frame: Postoperative 24th hour
Change of Procalcitonin (µg/l)
Time frame: Postoperative 24th hour
Change of Ferritin (ml/ng)
Time frame: Postoperative 24th hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Derived from this study: PubMed 42154167Dikmen Demiryorgan B, Nalbant B, Demiryorgan F, Kavak Akelma F. The effect of unilateral inguinal hernia surgery performed at different times of the day on inflammation and recovery: a prospective randomized controlled study. Updates Surg. 2026 May 19. doi: 10.1007/s13304-026-02669-9. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Inflammatory Response
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Change in Platelet Lipid Metabolism and Procoagulant Phenotype Induced by Cardiopulmonary Bypass. Impact on Postoperative Inflammatory Response and Bleeding Complications During Cardiac Surgery.
Cardiac Surgery, Cardiopulmonary Bypass
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Day Group and Night Group in people with Inflammatory Response, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of IL6 (interleukin6) (ng/ml) (time frame: Postoperative 24th hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06345313, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.