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临床试验/NCT00268073
NCT00268073终止不适用

Comparison of the Incidence of Neo-Aortic Insufficiency After Classic Norwood I and Norwood I-Sano Procedures

Children's Healthcare of Atlanta1 个研究点 分布在 1 个国家开始时间: 2002年1月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
试验地点
1

研究概览

简要总结

The records of all the patients that underwent the Norwood-Sano operation at Children's Healthcare of Atlanta, Emory University between January 1, 2002 and December 31, 2004 will be investigated. These patients will be compared with an equal number of consecutive cases treated by classic Norwood stage I operation in order to determine the incidence of neo-aortic valve insufficiency and the clinical outcome of these patients.

详细描述

Neoaortic valve insufficiency after Norwood type palliation of single ventricle patients has not been well studied. Patients with mild insufficiency tolerate it well; moderate to severe insufficiency however is poorly tolerated and can result in the death of the patient or at least require re-operation. Re-operation for neo-aortic insufficiency in this small size child is a difficult operation and the operative options are very limited. The introduction of the Sano modification of the Norwood procedure introduced a new set of variables due to the presence of a ventricular incision and possible distortion of the neo-aortic valve. It is therefore critical to determine the incidence of neo-aortic insufficiency and compare it to the standard Norwood operation, as well as to determine the clinical consequences of the presence of this phenomenon immediately postoperatively as well as long-term, up to completion of the stage II of the Norwood procedure (Glenn stage).

研究设计

研究类型
Observational
观察模型
Defined Population
时间视角
Retrospective

入排标准

年龄范围
— 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • patients undergone Norwood-Sano at Children's Healthcare of Atlanta between 9.2.2002 and 12.31.2004
  • equal number of consecutive patients undergone Norwood classic stage I at Children's Healthcare of Atlanta between 9.2.2002 and 12.31.2004

排除标准

  • those who do not meet the inclusion criteria

研究者

申办方类型
Other

研究点 (1)

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