Enhanced Recovery After Thoracic Surgery

Thoracic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05329311
• Other study ID #: 2012-KAEK-15/2319
• Status: Completed
• Start date: March 16, 2022
• Est. completion date: June 16, 2022

Study information

• Verified date: June 2022
• Source: Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 16, 2022
• Est. primary completion date: May 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm, Dissecting
• C-reactive Protein
• Thoracic Surgery

Intervention

Procedure:
• ERATS protocol applied
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 (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.

Locations

Country	Name	City	State
Turkey	Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital	Kecioren	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative C-reactive protein	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
Primary	Postoperative white blood cell count	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
Primary	Postoperative neutrophil/lymphocyte ratio	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
Primary	Postoperative platelet/lymphocyte ratio	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
Primary	Postoperative lymphocyte/monocytes ratio	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