跳至主要内容
临床试验/NCT03799965
NCT03799965Unknown不适用

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

Kocaeli Derince Education and Research Hospital2 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2017年12月1日最近更新:
适应症
干预措施

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

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

Active Comparator
  • 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

Active Comparator
  • 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

发起方
Kocaeli Derince Education and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ipek Yakin Duzyol

specialist doctor

Kocaeli Derince Education and Research Hospital

研究点 (2)

Loading locations...

相似试验

The Effect of Advanced Improvement Program (ERAS) on... | 临床试验