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Clinical Trials/NCT03799965
NCT03799965
Unknown
Not Applicable

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

Kocaeli Derince Education and Research Hospital1 site in 1 country210 target enrollmentDecember 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Enhanced Recovery After Surgery
Sponsor
Kocaeli Derince Education and Research Hospital
Enrollment
210
Locations
1
Primary Endpoint
complications
Last Updated
7 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2017
End Date
June 1, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Kocaeli Derince Education and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Ipek Yakin Duzyol

specialist doctor

Kocaeli Derince Education and Research Hospital

Eligibility 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.

Outcomes

Primary Outcomes

complications

Time Frame: 24 hours

compare the incidences of complications

durations of stay

Time Frame: 24 hours

compare the durations of stay in the intensive care unit and in hospital

Study Sites (1)

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