Investigation of the Effect of Enhanced Recovery After Surgery (ERAS) Program on Postoperative Results of Patients Operated for Open Heart Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- complications
研究概览
简要总结
Investigation of the effect of Enhanced Recovery After Surgery (ERAS) program on postoperative results of patients operated for open heart surgery.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Patients who refuse to participate in the study;
- •Patients under emergency conditions.
研究组 & 干预措施
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
干预措施: ERAS (Enhanced Recovery After Surgery ) are evaluated (Other)
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
干预措施: ERAS are not evaluated (Other)
结局指标
主要结局
complications
时间窗: 24 hours
compare the incidences of complications
durations of stay
时间窗: 24 hours
compare the durations of stay in the intensive care unit and in hospital
次要结局
未报告次要终点
研究者
Ipek Yakin Duzyol
specialist doctor
Kocaeli Derince Education and Research Hospital
