Fenestrated Vs Non Fenestrated Extra-Cardiac Total Cavo-pulmonary Connection in Patients With Standard Preoperative Risk Profiles, A Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Duration of chest tube drainage
研究概览
简要总结
Evaluation of fenestration benefit in Extra-cardiac total cavo-pulmonary connection (Fontan procedure) in single ventricle anomaly, comparing clinical outcomes of patients with low preoperative risk profiles in prospective study
详细描述
Study Population:
This study will include all patients referred for an elective Fontan procedure at the period of the study, who demonstrated a standard risk profile. An Informed consent will be obtained from the guardians before enrollment in the investigation. All procedures followed will be in accordance with institutional guidelines.
Randomization Technique:
Patients will be assigned to undergo either a fenestrated or non-fenestrated Extra-cardiac Fontan, based on a table of randomly generated numbers. Preoperative clinical data will be collected and compared to ensure appropriate randomization.
Preoperative Evaluation:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •This study will includeall patients referred for an elective TCPC procedure at the period of the study, who demonstrated a standard risk profile
- •Preoperative evaluation consisted of ECG, transthoracic echocardiogram, and complete cardiac catheterization.
- •Patients with the following parameters will be eligible for enrollment in the study:
- •Sinus Rhythm
- •Atriovnetricular valve regurgitation not more than mild
- •Aortic (neoaortic) valve regurgitation not more than mild
- •Normal systolic dominant ventricle function
- •Mean pulmonary artery pressure not more than 15 mmHg (measured directly or estimated by pulmonary vein wedge pressure)
- •Pulmonary vascular resistance not more than 2 woods unit
- •End diastolic ventricular filling pressure not more than 8 mm Hg
- •Patient with the following will not be eligible for inclusion:
- •Patients with pulmonary artery distortion, stenosis or thrombus requiring surgical or interventional additional procedures before or during the Fontan operation.
- •Pacemaker insertion before or during Fontan operation.
- •Significant pulmonary arteriovenous malformations (AVMs) rendering fenestration potentially a cause of excessive cyanosis.
- •Patients for whom the cardiology/cardiac surgery case conference decision is strongly in favor of fenestration for any other cause.
排除标准
- 未提供
结局指标
主要结局
Duration of chest tube drainage
时间窗: through study completion, an average of 1 year
Total duration of days patient has been having chest tube inserted in his pleural cavities
次要结局
- Stroke(through study completion, an average of 1 year)
- Length of intensive care unit stay(through study completion, an average of 1 year)
- Death(Post operation and through 90 days of discharge from hospital)
- Length of hospital stay(through study completion, an average of 1 year)
- Total amount of chest tube drainage(through study completion, an average of 1 year)
- Number of additional procedures(through study completion, an average of 1 year)
- Readmissions(through study completion, an average of 1 year)