The Effects of Surgery Performed At Different Times of the Day on Inflammation and Recovery

NCT06345313 | Completed

• 1 other identifier: Inflammation
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Inflammatory Response

Keywords

CIRCADIAN RHYTHM; POSTOPERATİVE RECOVERY

Outcome Measures

Primary Outcomes (1)

• 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.

  Postoperative 24th hour

Secondary Outcomes (9)

• Quality of recovery from anesthesia according to difference in circadian rhythm

  Postoperative 24th hour

• Change of NLR ( Neutrophil/ Lymphocyte Ratio )

  Postoperative 24th hour

• Change of PLR ( Platelet / Lymphocyte Ratio )

  Postoperative 24th hour

• Change of SII (Systemic immune-inflammation index )

  Postoperative 24th hour

• Change of CRP (C Reactive Protein) (mg/dl)

  Postoperative 24th hour

Other Outcomes (1)

• Numeric Rating Scale (NRS)

  Postoperative 24th hour

Study Arms (2)

Day Group

ACTIVE COMPARATOR

Participants who underwent inguinal herniography operation between 08.00-12.00

Procedure: Day Group

Night Group

ACTIVE COMPARATOR

Participants who underwent inguinal herniography operation between 18.00-22.00

Procedure: Night Group

Interventions

Day Group PROCEDURE

Patient group that will be operated on between 08.00-12.00

Day Group

Night Group PROCEDURE

Patient group that will be operated on between 18.00-22.00

Night Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Have bilateral herniorrhaphy surgery
• Complicated inguinal hernia (incarcerated, strangulated…)
• Pregnancy
• Emergency surgeries
• Laparoscopic surgeries
• Develop an unexpected intraoperative surgical complication

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, CANKAYA, 06800, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: April 3, 2024
• Study Start: April 15, 2024
• Primary Completion: October 15, 2024
• Study Completion: November 15, 2024
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)