ERAS ProgrammesNCT07817264
EFFECTS OF ERAS PROTOCOLS ON PATIENT OUTCOMES IN CARDIOVASCULAR SURGERY
A study testing Enhanced Recovery After Surgery (ERAS) Protocol in people with ERAS Programmes, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial summary
A randomized controlled experimental study has been conducted to determine the effects of Enhanced Recovery After Surgery (ERAS) protocols on patient outcomes in the Cardiovascular Surgery Clinic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ERAS Programmes
- What is being tested?
- Enhanced Recovery After Surgery (ERAS) Protocol
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Oct 2024to 30 May 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being admitted for their first planned coronary artery bypass graft (CABG) surgery;
- Undergoing off-pump coronary artery bypass (OPCAB) surgery without the use of a cardiopulmonary bypass machine;
- Not undergoing any additional surgical procedure during CABG surgery;
- Having no abnormalities in preoperative laboratory parameters, including hemoglobin, albumin, and electrolytes;
- Having no cognitive impairment;
- Having no psychological or mental disorder;
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- Being able to speak Turkish and communicate effectively;
- Being at least literate;
- Being 18 years of age or older;
- Being reachable by telephone during the follow-up period; and
- Providing informed consent to participate in the study.
Who cannot join
- Having previously undergone CABG surgery;
- Undergoing CABG surgery using cardiopulmonary bypass with the heart arrested;
- Undergoing any additional surgical procedure during CABG surgery;
- Having electrolyte abnormalities in preoperative laboratory parameters;
- Having cognitive impairment;
- Having a psychological or mental disorder;
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- Being unable to speak Turkish, communicate effectively, or provide consent to participate in the study;
- Being unable to read and write;
- Being younger than 18 years of age;
- Being unreachable by telephone during the follow-up period;
- Withdrawing from the study after initially agreeing to participate;
- Undergoing any surgical operation after hospital admission; or
- Dying during the study intervention or follow-up period.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bolu Abant İzzet Baysal University İzzet Baysal Training and Research Hospital
Bolu
About this study
Official title: THE EFFECTS OF ERAS PROTOCOLS ON PATIENT OUTCOMES IN CARDIOVASCULAR SURGERY
A randomized controlled experimental study has been conducted to determine the effects of Enhanced Recovery After Surgery (ERAS) protocols on patient outcomes in the Cardiovascular Surgery Clinic.
Read the detailed description
This randomized controlled trial was conducted to evaluate the effects of an Enhanced Recovery After Surgery (ERAS) protocol on postoperative recovery and patient outcomes in patients undergoing elective coronary artery bypass grafting (CABG) surgery. The study was conducted in the Cardiovascular Surgery Clinic of Bolu Abant İzzet Baysal University İzzet Baysal Training and Research Hospital. A total of 50 patients who met the eligibility criteria were included in the study and randomly assigned to either the ERAS group (n=25) or the control group (n=25). Patients in the ERAS group received a comprehensive perioperative care program based on ERAS principles. The ERAS program included preoperative oral carbohydrate loading, multimodal analgesia, prevention of postoperative nausea and vomiting, early extubation, respiratory exercises, coughing exercises, early mobilization, and other evidence-based perioperative interventions. Patients in the control group received routine perioperative care according to standard clinical practice. The primary outcomes included quality of recovery and postoperative clinical outcomes. Quality of recovery was assessed using the Quality of Recovery-40 (QoR-40) questionnaire. Secondary outcomes included anxiety, pain intensity, nutritional risk, postoperative delirium, and cardiovascular surgery-related symptoms. Clinical recovery outcomes included time to extubation, duration of intensive care unit stay, duration of surgical drain use, time to urinary catheter removal, time to first bowel movement, time to first oral intake, and length of hospital stay. Patients were evaluated at multiple time points throughout the postoperative recovery process. Assessments were performed during the intensive care unit stay, after transfer to the surgical ward, at hospital discharge, and at one week and one month after discharge. These repeated assessments were used to evaluate changes in quality of recovery, anxiety, pain, cardiovascular surgery-related symptoms, and other patient outcomes over time. The study aimed to determine whether implementation of a comprehensive ERAS protocol could improve quality of recovery, reduce postoperative symptoms and anxiety, facilitate earlier recovery, shorten intensive care unit and hospital stays, and contribute to improved clinical outcomes in patients undergoing cardiovascular surgery.
- Conditions
- ERAS Programmes
- Being tested
- Enhanced Recovery After Surgery (ERAS) Protocol
- Keywords
- ERAS, Postoperative Pain, Cardiac Surgery, Anxiety, Symptoms
- Medical subject headings
- Pain, Postoperative, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Recovery After Surgery (ERAS) ProtocolBehavioural
A comprehensive 31-factor Enhanced Recovery After Surgery (ERAS) program was implemented throughout the perioperative period in patients undergoing elective coronary artery bypass grafting (CABG) surgery. The program included patient education and counseling, nutritional assessment, preoperative oral carbohydrate loading, appropriate fasting, avoidance of mechanical bowel preparation, multimodal anesthesia and analgesia, lung-protective ventilation, normothermia, antimicrobial prophylaxis, blood conservation, prevention of postoperative nausea and vomiting, early extubation, respiratory physiotherapy, incentive spirometry, coughing and leg exercises, early mobilization and oral intake, thromboprophylaxis, glycemic control, systematic delirium screening, wound care, and early removal of chest tubes and urinary catheters when clinically appropriate. Quality of recovery, anxiety, pain, and cardiovascular surgery-related symptoms were assessed at predefined postoperative time points.
| Study group | Role | What they receive |
|---|---|---|
| ENHANCED RECOVERY AFTER SURGERY (ERAS) GROUP | Experimental | Patients in the ERAS group received a multimodal enhanced recovery program covering the preoperative, intraoperative, and postoperative periods. Interventions included patient education and counseling, nutritional assessment and support when indicated, preoperative oral carbohydrate loading, appropriate fasting, and avoidance of mechanical bowel preparation. Intraoperative interventions included multimodal anesthesia, lung-protective ventilation, maintenance of normothermia, antimicrobial prophylaxis, blood conservation, and minimization of surgical drains. Postoperative care included early extubation, respiratory physiotherapy, incentive spirometry, coughing and leg exercises, early mobilization and oral intake, multimodal analgesia, thromboprophylaxis, glycemic control, wound care, delirium screening, and early removal of chest tubes and urinary catheters when clinically appropriate. Quality of recovery, anxiety, pain, and cardiovascular surgery-related symptoms were assessed during Receives: Behavioral: Enhanced Recovery After Surgery (ERAS) Protocol |
| CONTROL GROUP | No intervention | Patients in the control group received routine perioperative care according to standard clinical practice. No specific Enhanced Recovery After Surgery (ERAS) protocol was applied. Patients received standard preoperative, intraoperative, and postoperative care, including routine monitoring, pain management, respiratory care, mobilization, nutritional management, and other clinical interventions as indicated by the treating healthcare team. Patient outcomes were assessed at the same time points as in the ERAS group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery-40 (QoR-40) Score
The scale is a 5-point Likert-type scale, and the total score ranges from 40 to 200 based on the sum of all items. A higher total score indicates that the patients' emotional and physical well-being is at the expected and favorable level following surgery, whereas a lower score indicates that their well-being has been adversely affected. With a Cronbach's alpha value of 0.936, the questionnaire is a valid and reliable instrument for assessing recovery following
Measured: one month
Secondary outcomes (1)
Cardiac Surgery-Related Symptom Score
The inventory is unidimensional and consists of 35 items. It is a Likert-type instrument, with each item scored from 0 to 4. The total score ranges from 0 to 140, with higher scores indicating greater symptom severity. The inventory has a total Cronbach's alpha coefficient of 0.961, and the total item correlations for all items are positive.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start30 Oct 2024
- Primary completion30 Oct 2024
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ERAS ProgrammesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After confirming that the individuals met the inclusion and exclusion criteria, eligible participants were randomly assigned to either the Enhanced Recovery After Surgery (ERAS) group or the control group using a one-to-one allocation ratio. Each participant had an equal probability of being assigned to either group, and the allocation was independent of previous assignments. The sealed envelope method was used to determine whether participants would be assigned to the ERAS or control group. The ERAS group was coded as "0" and the control group as "1". When an eligible participant was identified, a person who was not involved in the study was presented with a set of mixed, sealed envelopes and asked to randomly select one envelope. The selected envelope was then opened to determine the group to which the participant would be assigned. This procedure was used to minimize selection bias by ensuring that group allocation was performed randomly and independently of the researcher.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aynur Ülkü, Karabuk University
- Investigators
- Aynur Ülkü, Principal investigator, Karabuk Universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07817264
- Sponsor's protocol ID
- KarabukU-AUlku-1
- Status last verified
- Oct 2024
- First submitted
- 8 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant-level data will not be shared publicly due to patient privacy and confidentiality requirements. However, the aggregated results of the study will be reported and made available through scientific publication. No personally identifiable patient information will be included in the published results.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECTS OF ERAS PROTOCOLS ON PATIENT OUTCOMES IN CARDIOVASCULAR SURGERY
- ClinicalTrials.gov ID
- NCT07817264
- Acronym / sponsor ID
- KarabukU-AUlku-1
- Conditions
- ERAS Programmes
- Keywords
- ERAS, Postoperative Pain, Cardiac Surgery, Anxiety, Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 30 Oct 2024 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 14 Sep 2026 (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.
A randomized controlled experimental study has been conducted to determine the effects of Enhanced Recovery After Surgery (ERAS) protocols on patient outcomes in the Cardiovascular Surgery Clinic.
Detailed description
This randomized controlled trial was conducted to evaluate the effects of an Enhanced Recovery After Surgery (ERAS) protocol on postoperative recovery and patient outcomes in patients undergoing elective coronary artery bypass grafting (CABG) surgery. The study was conducted in the Cardiovascular Surgery Clinic of Bolu Abant İzzet Baysal University İzzet Baysal Training and Research Hospital. A total of 50 patients who met the eligibility criteria were included in the study and randomly assigned to either the ERAS group (n=25) or the control group (n=25). Patients in the ERAS group received a comprehensive perioperative care program based on ERAS principles. The ERAS program included preoperative oral carbohydrate loading, multimodal analgesia, prevention of postoperative nausea and vomiting, early extubation, respiratory exercises, coughing exercises, early mobilization, and other evidence-based perioperative interventions. Patients in the control group received routine perioperative care according to standard clinical practice. The primary outcomes included quality of recovery and postoperative clinical outcomes. Quality of recovery was assessed using the Quality of Recovery-40 (QoR-40) questionnaire. Secondary outcomes included anxiety, pain intensity, nutritional risk, postoperative delirium, and cardiovascular surgery-related symptoms. Clinical recovery outcomes included time to extubation, duration of intensive care unit stay, duration of surgical drain use, time to urinary catheter removal, time to first bowel movement, time to first oral intake, and length of hospital stay. Patients were evaluated at multiple time points throughout the postoperative recovery process. Assessments were performed during the intensive care unit stay, after transfer to the surgical ward, at hospital discharge, and at one week and one month after discharge. These repeated assessments were used to evaluate changes in quality of recovery, anxiety, pain, cardiovascular surgery-related symptoms, and other patient outcomes over time. The study aimed to determine whether implementation of a comprehensive ERAS protocol could improve quality of recovery, reduce postoperative symptoms and anxiety, facilitate earlier recovery, shorten intensive care unit and hospital stays, and contribute to improved clinical outcomes in patients undergoing cardiovascular surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- After confirming that the individuals met the inclusion and exclusion criteria, eligible participants were randomly assigned to either the Enhanced Recovery After Surgery (ERAS) group or the control group using a one-to-one allocation ratio. Each participant had an equal probability of being assigned to either group, and the allocation was independent of previous assignments. The sealed envelope method was used to determine whether participants would be assigned to the ERAS or control group. The ERAS group was coded as "0" and the control group as "1". When an eligible participant was identified, a person who was not involved in the study was presented with a set of mixed, sealed envelopes and asked to randomly select one envelope. The selected envelope was then opened to determine the group to which the participant would be assigned. This procedure was used to minimize selection bias by ensuring that group allocation was performed randomly and independently of the researcher.
| Arm | Type | Receives |
|---|---|---|
| ENHANCED RECOVERY AFTER SURGERY (ERAS) GROUP | Experimental | Behavioral: Enhanced Recovery After Surgery (ERAS) ProtocolPatients in the ERAS group received a multimodal enhanced recovery program covering the preoperative, intraoperative, and postoperative periods. Interventions included patient education and counseling, nutritional assessment and support when indicated, preoperative oral carbohydrate loading, appropriate fasting, and avoidance of mechanical bowel preparation. Intraoperative interventions included multimodal anesthesia, lung-protective ventilation, maintenance of normothermia, antimicrobial prophylaxis, blood conservation, and minimization of surgical drains. Postoperative care included early extubation, respiratory physiotherapy, incentive spirometry, coughing and leg exercises, early mobilization and oral intake, multimodal analgesia, thromboprophylaxis, glycemic control, wound care, delirium screening, and early removal of chest tubes and urinary catheters when clinically appropriate. Quality of recovery, anxiety, pain, and cardiovascular surgery-related symptoms were assessed during |
| CONTROL GROUP | No intervention | –Patients in the control group received routine perioperative care according to standard clinical practice. No specific Enhanced Recovery After Surgery (ERAS) protocol was applied. Patients received standard preoperative, intraoperative, and postoperative care, including routine monitoring, pain management, respiratory care, mobilization, nutritional management, and other clinical interventions as indicated by the treating healthcare team. Patient outcomes were assessed at the same time points as in the ERAS group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Being admitted for their first planned coronary artery bypass graft (CABG) surgery;
- Undergoing off-pump coronary artery bypass (OPCAB) surgery without the use of a cardiopulmonary bypass machine;
- Not undergoing any additional surgical procedure during CABG surgery;
- Having no abnormalities in preoperative laboratory parameters, including hemoglobin, albumin, and electrolytes;
- Having no cognitive impairment;
Key exclusion criteria (13 listed)
- Having previously undergone CABG surgery;
- Undergoing CABG surgery using cardiopulmonary bypass with the heart arrested;
- Undergoing any additional surgical procedure during CABG surgery;
- Having electrolyte abnormalities in preoperative laboratory parameters;
- Having cognitive impairment;
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 |
|---|---|---|
| Enhanced Recovery After Surgery (ERAS) ProtocolA comprehensive 31-factor Enhanced Recovery After Surgery (ERAS) program was implemented throughout the perioperative period in patients undergoing elective coronary artery bypass grafting (CABG) surgery. The program included patient education and counseling, nutritional assessment, preoperative oral carbohydrate loading, appropriate fasting, avoidance of mechanical bowel preparation, multimodal anesthesia and analgesia, lung-protective ventilation, normothermia, antimicrobial prophylaxis, blood conservation, prevention of postoperative nausea and vomiting, early extubation, respiratory physiotherapy, incentive spirometry, coughing and leg exercises, early mobilization and oral intake, thromboprophylaxis, glycemic control, systematic delirium screening, wound care, and early removal of chest tubes and urinary catheters when clinically appropriate. Quality of recovery, anxiety, pain, and cardiovascular surgery-related symptoms were assessed at predefined postoperative time points. | Behavioural | ENHANCED RECOVERY AFTER SURGERY (ERAS) GROUP |
Primary outcome
Quality of Recovery-40 (QoR-40) Score
Time frame: one month
The scale is a 5-point Likert-type scale, and the total score ranges from 40 to 200 based on the sum of all items. A higher total score indicates that the patients' emotional and physical well-being is at the expected and favorable level following surgery, whereas a lower score indicates that their well-being has been adversely affected. With a Cronbach's alpha value of 0.936, the questionnaire is a valid and reliable instrument for assessing recovery following
1 secondary outcome
Cardiac Surgery-Related Symptom Score
Time frame: one month
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 14 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant-level data will not be shared publicly due to patient privacy and confidentiality requirements. However, the aggregated results of the study will be reported and made available through scientific publication. No personally identifiable patient information will be included in the published results.
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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.
Aynur Ülkü principal investigator
Karabuk Universty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Recovery After Surgery (ERAS) Protocol in people with ERAS Programmes, run by Karabuk University 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 11 inclusion and 13 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 14 Sep 2026. 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?
Quality of Recovery-40 (QoR-40) Score (time frame: one month). 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 14 Sep 2026.