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Completed

NCT Number: NCT05329311

Enhanced Recovery After Thoracic Surgery

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.

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Key information

Conditions

Enhanced Recovery After Thoracic Surgery Protocol C-reactive Protein Lymphocyte/Monocytes Ratio Neutrophil/Lymphocyte Ratio Plathelet/ Lymphocyte Ratio Thoracic Surgery White Blood Cell Count

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital

Keçiören, Ankara, 06000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ERATS protocol applied

Procedure

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

Procedure

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 15, 2022
Registry last updated
Jun 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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