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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03799965
Recruitment Status : Unknown
Verified January 2019 by Ipek Yakin Duzyol, Kocaeli Derince Education and Research Hospital.
Recruitment status was:  Recruiting
First Posted : January 10, 2019
Last Update Posted : January 31, 2019
Sponsor:
Collaborator:
Kocaeli University
Information provided by (Responsible Party):
Ipek Yakin Duzyol, Kocaeli Derince Education and Research Hospital

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

Condition or disease Intervention/treatment Phase
Enhanced Recovery After Surgery Open Heart Surgery Other: ERAS (Enhanced Recovery After Surgery ) are evaluated Other: ERAS are not evaluated Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Investigation of the Effect of Enhanced Recovery After Surgery (ERAS) Program on Postoperative Results of Patients Operated for Open Heart Surgery
Actual Study Start Date : December 1, 2017
Actual Primary Completion Date : January 1, 2019
Estimated Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: ERAS protocol are evaluated
  • 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
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.
Active Comparator: ERAS protocol are not evaluated
  • 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
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.


Outcome Measures
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Primary Outcome Measures :
  1. durations of stay [ Time Frame: 24 hours ]
    compare the durations of stay in the intensive care unit and in hospital

  2. complications [ Time Frame: 24 hours ]
    compare the incidences of complications


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03799965


Contacts
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Contact: Ipek Y duzyol, doctor +905067922217 ipekyd@hotmail.com
Contact: emine yurt, doctor +905054782609 dremine@gmail.com

Locations
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Turkey
Emine yurt Recruiting
Kocaeli, Derince, Turkey, 41400
Contact: ipek y duzyol, doctor    +905067922217    ipekyd@hotmail.com   
Contact: emine yurt, doctor    +905054782609    dremine@gmail.com   
Sponsors and Collaborators
Kocaeli Derince Education and Research Hospital
Kocaeli University
More Information
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Responsible Party: Ipek Yakin Duzyol, specialist doctor, Kocaeli Derince Education and Research Hospital
ClinicalTrials.gov Identifier: NCT03799965    
Other Study ID Numbers: KUGOKAEK 2017/369
First Posted: January 10, 2019    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No