MedDataX Logo

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

NCT ID: NCT03799965

Last Updated: 2019-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2019-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Enhanced Recovery After Surgery Open Heart Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type ACTIVE_COMPARATOR

ERAS (Enhanced Recovery After Surgery ) are evaluated

Intervention Type OTHER

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 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

Group Type ACTIVE_COMPARATOR

ERAS are not evaluated

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kocaeli University

OTHER

Sponsor Role collaborator

Kocaeli Derince Education and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ipek Yakin Duzyol

specialist doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Emine yurt

Kocaeli, Derince, Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ipek Y duzyol, doctor

Role: CONTACT

Phone: +905067922217

Email: [email protected]

emine yurt, doctor

Role: CONTACT

Phone: +905054782609

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

ipek y duzyol, doctor

Role: primary

emine yurt, doctor

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KUGOKAEK 2017/369

Identifier Type: -

Identifier Source: org_study_id