Enhanced Recovery After Thoracic Surgery ProtocolNCT05329311
Enhanced Recovery After Thoracic Surgery
An observational study of Enhanced Recovery After Thoracic Surgery Protocol and C-reactive Protein, run by Atatürk Chest Diseases and Chest Surgery Training and Research Hospital at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Enhanced Recovery After Thoracic Surgery Protocol, C-reactive Protein, White Blood Cell Count
- What is being tested?
- ERATS protocol applied and ERATS protocol not applied
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Mar 2022to 16 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital
Keçiören, Ankara, 06000
About this study
Official title: 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.
- Conditions
- Enhanced Recovery After Thoracic Surgery Protocol, C-reactive Protein, White Blood Cell Count, Neutrophil/Lymphocyte Ratio, Plathelet/ Lymphocyte Ratio, Lymphocyte/Monocytes Ratio
- Being tested
- ERATS protocol applied, ERATS protocol not applied
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERATS protocol appliedProcedure or surgery
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 appliedProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| ERATS protocol applied | Inflammatory parameters of the operated patients by applying the ERATS protocol will be investigated. Receives: Procedure: ERATS protocol applied | |
| ERATS protocol not applied | Inflammatory parameters of patients who were operated without the ERATS protocol will be investigated. Receives: Procedure: ERATS protocol not applied |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline CRP on the first, third, and fifth postoperative days
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.
Measured: Change from baseline WBC on the first, third, and fifth postoperative days
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.
Measured: Change from baseline NLR on the first, third, and fifth postoperative days
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.
Measured: Change from baseline PLR on the first, third, and fifth postoperative days
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.
Measured: Change from baseline LMR on the first, third, and fifth postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start16 Mar 2022
- Primary completion15 May 2022
- Study completion16 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enhanced Recovery After Thoracic Surgery ProtocolStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Musa Zengin, Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05329311
- Sponsor's protocol ID
- 2012-KAEK-15/2319
- Status last verified
- Jun 2022
- First submitted
- 16 Mar 2022
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Enhanced Recovery After Thoracic Surgery Protocol on Inflammatory Markers
- ClinicalTrials.gov ID
- NCT05329311
- Acronym / sponsor ID
- 2012-KAEK-15/2319
- Conditions
- Enhanced Recovery After Thoracic Surgery Protocol, C-reactive Protein, White Blood Cell Count, Neutrophil/Lymphocyte Ratio, Plathelet/ Lymphocyte Ratio, Lymphocyte/Monocytes Ratio
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Atatürk Chest Diseases and Chest Surgery Training and Research HospitalUniversity, hospital or other
- Study start
- 16 Mar 2022 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 16 Jun 2022 (actual)
- First posted
- 15 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERATS protocol applied | – | Procedure: ERATS protocol appliedInflammatory parameters of the operated patients by applying the ERATS protocol will be investigated. |
| ERATS protocol not applied | – | Procedure: ERATS protocol not appliedInflammatory parameters of patients who were operated without the ERATS protocol will be investigated. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERATS protocol appliedInflammatory 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. | Procedure or surgery | ERATS protocol applied |
| ERATS protocol not appliedInflammatory 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. | Procedure or surgery | ERATS protocol not applied |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Enhanced Recovery After Thoracic Surgery Protocol and C-reactive Protein, run by Atatürk Chest Diseases and Chest Surgery Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative C-reactive protein (time frame: Change from baseline CRP on the first, third, and fifth postoperative days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2022; AzTrials last refreshed its copy on 31 Oct 2026.