Enhanced Recovery After Thoracic Surgery

The Effect of Enhanced Recovery After Thoracic Surgery Protocol on Inflammatory Markers

Despite significant advances in perioperative care, major complications continue to be seen in patients undergoing major surgery. Enhanced recovery after surgery (ERAS) protocols are perioperative care practices designed to reduce perioperative complications, maintain preoperative organ function, and provide early recovery by reducing the psychological and physiological response to major surgery and the intense stress response that develops following surgery. In this context, ERAS protocols have been established for many surgical procedures. One is the thoracic ERAS (ERATS) protocol applied to thoracic surgery, and the evidence for ERATS is increasing; literature data support the application of ERATS. However, there are limited studies on the application of ERAS protocols to thoracic surgery, and more studies are needed to develop ERATS protocols.

Postoperative complications may be reduced in patients who are treated with the ERAS protocol, their length of hospital stay (LOS) may be shortened, and patients may regain their initial functions faster. Objectively, a marker indicating whether the ERAS protocol can be implemented effectively has not yet been demonstrated. Reducing postoperative inflammation is thought to reduce LOS. Based on this, the investigators think that the early recovery seen in patients who undergo ERAS is due to the effect of ERAS protocols on the inflammatory process. Therefore, laboratory parameters such as C-reactive protein (CRP), white blood cell count, neutrophil/lymphocyte ratio (NLR), platelet/lymphocyte ratio (PLR), lymphocyte/monocytes ratio (LMR) may differ in patients who have undergone the ERAS protocol compared to patients who have not. These parameters have been evaluated comprehensively in studies as inflammatory parameters. In addition, clinical studies indicate that the C-reactive protein to albumin ratio (CAR) can be used as inflammatory and prognostic markers. Also, the investigators hypothesized that inflammatory parameters used in routine clinical follow-up may be effective in evaluating the clinical consequences of ERATS protocols. In this study, the investigators aimed to evaluate the effects of the ERATS protocol on postoperative inflammatory parameters and investigate whether these parameters have a role in evaluating the effectiveness of the ERATS protocol.

Study Overview

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ankara
      • Kecioren, Ankara, Turkey, 06000
        • Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study included patients between 18-80 years of age who had undergone elective thoracic surgery, whose physical condition was I-II-III according to the ASA, and whose BMI was between 18.5-35 kg/m2.

Description

Inclusion Criteria:

  • Patients between 18-80 years of
  • Patients underwent elective thoracic surgery,
  • American Society of Anesthesiologists (ASA) I-II-III
  • Body mass index (BMI) between 18.5-35 kg/m2

Exclusion Criteria:

  • Patients with systemic inflammatory diseases
  • Patients with a history of anti-inflammatory and anti-allergic drugs,
  • Patients with a history of corticosteroid usage,
  • Patients who had received intraoperative blood product transfusions,
  • Patients who had previously undergone thoracic surgery,
  • Patients with missing data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ERATS protocol applied
Inflammatory parameters of the operated patients by applying the ERATS protocol will be investigated.
Inflammatory parameters (such as; C-reactive protein (CRP), white blood cell count, neutrophil/lymphocyte ratio (NLR), platelet/ lymphocyte ratio (PLR), lymphocyte/monocytes ratio (LMR) of the operated patients by applying the ERATS protocol will be investigated.
ERATS protocol not applied
Inflammatory parameters of patients who were operated without the ERATS protocol will be investigated.
Inflammatory parameters (such as; C-reactive protein (CRP), white blood cell count, neutrophil/lymphocyte ratio (NLR), platelet/ lymphocyte ratio (PLR), lymphocyte/monocytes ratio (LMR) of the operated patients by applying without the ERATS protocol will be investigated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative C-reactive protein
Time Frame: Change from baseline CRP on the first, third, and fifth postoperative days

The postoperative C-reactive protein (CRP) (mg/L) of patients who had thoracic surgery will be investigated from the hospital archive.

The results of the patients who were operated on according to the ERATS protocol and who were operated on without ERATS protocol did will be compared.

Change from baseline CRP on the first, third, and fifth postoperative days
Postoperative white blood cell count
Time Frame: Change from baseline WBC on the first, third, and fifth postoperative days

The postoperative white blood cell count (WBC) (x10^3/µL) of patients who had thoracic surgery will be investigated from the hospital archive.

The results of the patients who were operated on according to the ERATS protocol and who were operated on without ERATS protocol did will be compared.

Change from baseline WBC on the first, third, and fifth postoperative days
Postoperative neutrophil/lymphocyte ratio
Time Frame: Change from baseline NLR on the first, third, and fifth postoperative days

The postoperative neutrophil/lymphocyte ratio (NLR) of patients who had thoracic surgery will be investigated from the hospital archive.

The results of the patients who were operated on according to the ERATS protocol and who were operated on without ERATS protocol did will be compared.

Change from baseline NLR on the first, third, and fifth postoperative days
Postoperative platelet/lymphocyte ratio
Time Frame: Change from baseline PLR on the first, third, and fifth postoperative days

The postoperative platelet/lymphocyte ratio (PLR) of patients who had thoracic surgery will be investigated from the hospital archive.

The results of the patients who were operated on according to the ERATS protocol and who were operated on without ERATS protocol did will be compared.

Change from baseline PLR on the first, third, and fifth postoperative days
Postoperative lymphocyte/monocytes ratio
Time Frame: Change from baseline LMR on the first, third, and fifth postoperative days

The postoperative lymphocyte/monocytes ratio (LMR) of patients who had thoracic surgery will be investigated from the hospital archive.

The results of the patients who were operated on according to the ERATS protocol and who were operated on without ERATS protocol did will be compared.

Change from baseline LMR on the first, third, and fifth postoperative days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 16, 2022

Primary Completion (ACTUAL)

May 15, 2022

Study Completion (ACTUAL)

June 16, 2022

Study Registration Dates

First Submitted

March 16, 2022

First Submitted That Met QC Criteria

April 12, 2022

First Posted (ACTUAL)

April 15, 2022

Study Record Updates

Last Update Posted (ACTUAL)

June 21, 2022

Last Update Submitted That Met QC Criteria

June 16, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 2012-KAEK-15/2319

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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