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

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

Study Overview

• Status: Unknown
• Conditions: Enhanced Recovery After Surgery; Open Heart Surgery
• Intervention / Treatment: Other: ERAS (Enhanced Recovery After Surgery ) are evaluated; Other: ERAS are not evaluated

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 Type: Interventional
• Enrollment (Anticipated): 210
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ipek y duzyol, doctor; Phone Number: +905067922217; Email: ipekyd@hotmail.com
• Study Contact Backup: Name: emine yurt, doctor; Phone Number: +905054782609; Email: dremine@gmail.com

Study Locations

• Turkey
  • Derince
    • Kocaeli, Derince, Turkey, 41400
      • Recruiting
      • Emine yurt
      • Contact: ipek y duzyol, doctor; Phone Number: +905067922217; Email: ipekyd@hotmail.com
      • Contact: emine yurt, doctor; Phone Number: +905054782609; Email: dremine@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
durations of stay	compare the durations of stay in the intensive care unit and in hospital	24 hours
complications	compare the incidences of complications	24 hours

Collaborators and Investigators

• Sponsor: Kocaeli Derince Education and Research Hospital
• Collaborators: Kocaeli University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): January 1, 2019
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: December 30, 2018
• First Submitted That Met QC Criteria: January 9, 2019
• First Posted (Actual): January 10, 2019

Study Record Updates

• Last Update Posted (Actual): January 31, 2019
• Last Update Submitted That Met QC Criteria: January 30, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: KUGOKAEK 2017/369

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No