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

Enhanced Recovery After Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03799965
• Other study ID #: KUGOKAEK 2017/369
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: June 1, 2019

Study information

• Verified date: January 2019
• Source: Kocaeli Derince Education and Research Hospital
• Contact: Ipek Y duzyol, doctor
• Phone: +905067922217
• Email: ipekyd[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: June 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Enhanced Recovery After Surgery
• Open Heart Surgery

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Emine yurt	Kocaeli	Derince

Sponsors (2)

Lead Sponsor	Collaborator
Kocaeli Derince Education and Research Hospital	Kocaeli University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	durations of stay	compare the durations of stay in the intensive care unit and in hospital	24 hours
Primary	complications	compare the incidences of complications	24 hours