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

Not Applicable

• Conditions: Enhanced Recovery After Surgery; Open Heart Surgery

• Registration Number: NCT03799965
• Lead Sponsor: Kocaeli Derince Education and Research Hospital

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.

Study Timeline

• Study Start: 2017-12-01
• Study First Submitted: 2018-12-30
• Status Verified: 2019-01
• Primary Completion: 2019-01-01
• Study First Submitted QC: 2019-01-09
• Study First Posted: 2019-01-10
• Last Update Submitted: 2019-01-30
• Last Update Posted: 2019-01-31
• Study Completion: 2019-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 210

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
complications	24 hours	compare the incidences of complications
durations of stay	24 hours	compare the durations of stay in the intensive care unit and in hospital

Trial Locations

Locations (1)

Emine yurt; 🇹🇷 Kocaeli, Derince, Turkey