跳至主要内容
临床试验/NCT02325700
NCT02325700已完成不适用

Total Laparoscopic Versus Open Aortic Surgery for Abdominal Aortic Disease. A Prospective Study With Propensity Analysis

University of Poitiers0 个研究点目标入组 228 人开始时间: 2006年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
228
主要终点
Composite adverse events (bypass occlusion, bleeding, graft infection, redo)

研究概览

简要总结

This prospective study was designed to analyse the postoperative and long-term outcomes of total laparoscopic vs. open surgical repair of infra-renal abdominal aortic occlusive disease (AOD) and infra-renal aortic aneurysmal disease (AAA) in comparable groups of patients using a propensity analysis model.

详细描述

From January 2006 to January 2010, 228 consecutive patients who received an aortic bypass for AAA (n=139) or for AOD (n=89) were studied. Open repair was performed in145 patients (AAA=109, AOD=36) and total laparoscopic repair in 83 patients (AAA=30, AOD=53). One-to-one propensity score matching between study groups was done according to a difference in the logit of propensity score of less than 0.04 between each patient pairs in the study groups. Logistic regression with the help of backward selection was used to adjust the effect of treatment method for propensity score as well as other variables in evaluating postoperative and long-term outcome. A p value < .05 was considered statistically significant.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
30 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aortic occlusive disease (TASC C & D)
  • Aortic abdominal aneurysm with a diameter > 5 cm

排除标准

  • Patients with an occlusive disease amenable to stenting (TASC A & B)
  • Patients with an abdominal aortic aneurysm with an anatomy allowing the use of a stent graft (EVAR)
  • Patients with a life expectancy < 3 years or ASA 4 with a high operative risk

结局指标

主要结局

Composite adverse events (bypass occlusion, bleeding, graft infection, redo)

时间窗: 0 to 6 years postoperative

Any of these complications occurring during this time frame

次要结局

  • Mortality(0 to 6 years postoperative)

研究者

申办方类型
Other
责任方
Sponsor

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