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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03799965
Enrollment
210
Registered
2019-01-10
Start date
2017-12-01
Completion date
2019-06-01
Last updated
2019-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enhanced Recovery After Surgery, Open Heart Surgery

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.

Interventions

OTHERERAS (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.

OTHERERAS 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.

Sponsors

Kocaeli University
CollaboratorOTHER
Kocaeli Derince Education and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
durations of stay24 hourscompare the durations of stay in the intensive care unit and in hospital
complications24 hourscompare the incidences of complications

Countries

Turkey (Türkiye)

Contacts

Primary ContactIpek Y duzyol, doctor
ipekyd@hotmail.com+905067922217
Backup Contactemine yurt, doctor
dremine@gmail.com+905054782609

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026