- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05329311
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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Ankara
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Kecioren, Ankara, Turkey, 06000
- Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012-KAEK-15/2319
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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