The Effect of Advanced Improvement Program (ERAS) on Postoperative Outcomes in Patients Undergoing Open Heart Surgery

Study Overview
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Brief Summary
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Investigation of the effect of Enhanced Recovery After Surgery (ERAS) program on postoperative results of patients operated for open heart surgery.

Detailed Description
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The ERAS protocol, also known as evidence based fast-track surgery (FTS), is an evidence based combination of findings regarding suggestions for patient care on various levels of the perioperative period, which work in synergy for accelerating the postoperative recovery period. It has been used sucessfully for many surgical disciplines, primarily colorectal surgery, since it was first reported in 1997. However, there is a significant insufficiency of this patient oriented rehabilitation program regarding cardiovascular surgeries. This study is to compare the postoperative follow up periods of patients with ERAS protocol and patients with standard protocol who were both operated for cardiac surgery. Following approval of the local ethics committee, 210 patients who are operated for elective cardiac surgery are enrolled in this prospective randomized clinical trial. The patients who are not applied the ERAS protocol are evaluated in the control group (n=51). The findings regarding the patients under ERAS protocol are evaluated based on evidence. Our primary is to compare the durations of stay in the intensive care unit and in hospital; our secondary is to compare the incidences of complications of the groups. The demographic data, operative measurements, complication rates, the amounts of perioperative bleeding and drainage and the duration of stay in the intensive care unit and hospital are recorded.

Official Title
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Investigation of the Effect of Enhanced Recovery After Surgery (ERAS) Program on Postoperative Results of Patients Operated for Open Heart Surgery

Conditions
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Enhanced Recovery After Surgery, Open Heart Surgery

Intervention / Treatment
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* Other: ERAS (Enhanced Recovery After Surgery ) are evaluated
* Other: ERAS are not evaluated


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: over 18 years old; Patients undergoing elective open heart surgery (cardiopulmonarybiasis, aortic and mitral valve replacement); ASA III ; Patients with informed consent for the study. Exclusion Criteria: Patients who refuse to participate in the study; Patients under emergency conditions.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ERAS protocol are evaluated<br>It is to compare the durations of stay in the intensive care unit and in hospital It is to compare the incidences of complications of the groups | Other: ERAS (Enhanced Recovery After Surgery ) are evaluated<br>* In this arm ERAS( Enhanced Recovery After Surgery) protocol will be inserted.The findings regarding the patients under ERAS protocol are evaluated based on evidence.<br>|
| Active Comparator: ERAS protocol are not evaluated<br>It is to compare the durations of stay in the intensive care unit and in hospital It is to compare the incidences of complications of the groups | Other: ERAS are not evaluated<br>* In this arm ERAS( Enhanced Recovery After Surgery) protocol will not be inserted.The findings regarding the patients under ERAS protocol are evaluated based on evidence.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| durations of stay | compare the durations of stay in the intensive care unit and in hospital | 24 hours | 
| complications | compare the incidences of complications | 24 hours |