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临床试验/NCT03902717
NCT03902717已完成不适用

An Observational Cohort Study to Investigate Patient-centered and Clinical Outcomes After Minimally Invasive Cardiothoracic Surgery

Jessa Hospital2 个研究点 分布在 1 个国家目标入组 209 人开始时间: 2019年11月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
209
试验地点
2
主要终点
Quality of Recovery

研究概览

简要总结

Nowadays, minimally invasive cardiothoracic surgery techniques are being performed to treat patients with coronary heart diseases. These newly developed procedures include laparoscopic techniques that do not require median sternotomy, which has several beneficial effects for both patient and the hospital. Although retrospective data show promising results with respect to clinical outcomes (e.g. 30-day mortality rate, intensive care unit length of stay), no prospective data with respect to patient centered outcomes (e.g. quality of recovery, quality of life) are available yet. Therefore, the aim of this observational prospective study is to explore several patient centered and clinical outcomes of patients that are treated with these newly developed minimally invasive cardiac procedures. The comparative group consists of patients undergoing open CABG (invasive) and patients undergoing a Transcatheter Aortic Valve Implantation (TAVI).

详细描述

Introduction:

Coronary artery disease is a leading cause of adult mortality worldwide. One of the most commonly performed surgical interventions to treat this vascular disease is a myocardial revascularization, mostly performed via a Coronary Artery Bypass Graft (CABG) (1). Over time, new developments in cardiac surgery have led to the introduction of less invasive and minimally invasive cardiac procedures (2). These minimally invasive cardiac procedures are proven to be safe and feasible (3) and have excellent outcomes (4) (5) (6). More specifically, the short term outcomes include a reduced patient recovery time (5), lower transfusion rates, wound infections, hospitalization time and hospital mortality rate (4), while the long term outcomes comprise a better vessel graft patency (7) (8). Over the past few years, new minimally invasive cardiothoracic surgery techniques have been developed and are currently being implemented at the department of cardiothoracic surgery from the Jessa Hospital (e.g. endo-CABG, VATS Mitral, hybrid revascularization, Yil AVR). These newly developed procedures include laparoscopic techniques that do not require median sternotomy, which has several beneficial effects for both patient and the hospital. Also, these techniques allow a coronary revascularization or mitral valve repair or replacement without the use of expensive robotic equipment and exclusion of specific patients based on comorbidities (e.g. elderly patients, diabetic and/or obese patients). Currently, patients undergo cardiothoracic surgery via these techniques and although retrospective data from our hospital show promising results with respect to clinical outcomes (e.g. 30-day mortality rate, intensive care unit length of stay), no prospective data with respect to patient centered outcomes (e.g. quality of recovery, quality of life) are available yet. Therefore, the aim of this study is to explore several patient centered and clinical outcomes of patients that are treated with these newly developed minimally invasive cardiac procedures.The comparative group consists of patients undergoing open CABG (invasive) and patients undergoing a Transcatheter Aortic Valve Implantation (TAVI).

Outcome measures:

The goal of this study is to assess several patient central outcomes (e.g. quality of recovery measured with quality of life) and clinical outcomes (e.g. mortality rate, serious complications, major cardiac events, time registration in icu and hospital, duration of surgery, occlusion and perfusion time, surgical parameters, revalidation of the patients) after minimally invasive cardiothoracic surgery.

Design:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Males and females ≥ 18 years of age
  • Patients planned to undergo minimally invasive cardiac surgery by the following techniques:
  • Endo-CABG
  • Hybrid approach
  • VATS Mitral
  • Yil AVR or open CABG or TAVI

排除标准

  • Patients < 18 years old
  • Patients that are not eligible to undergo minimally invasive cardiac surgery
  • Patients that participate in other clinical, pharmaceutical or medical devices trials
  • Patients that previously had a minimally invasive cardiac surgery and are now scheduled for a revision
  • Patients that need a conversion to sternotomy or other non-minimally invasive technique
  • Inability to understand and adhere to the study design

结局指标

主要结局

Quality of Recovery

时间窗: 1 month after surgery

Quality of Recovery will be assessed via 2 questionnaires: the SF-36 and EQ-5D questionnaire concerning mobility, selfcare, daily activities and pain

次要结局

  • Quality of Recovery(12 months after surgery)
  • Patient satisfaction with respect to surgery(3 months after surgery)
  • Routine measurements of standard medical practice(12 months after surgery)
  • Physical recovery of patients after surgery(12 months after surgery)

研究者

发起方
Jessa Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Stessel Björn

Principal Investigator, Anesthesiologist, MD, PhD

Jessa Hospital

研究点 (2)

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