跳至主要内容
临床试验/NCT06201338
NCT06201338招募中不适用

Pre-operative Screening of Functional Fragilities Before Open Aortic Surgery : a New Area

University Paul Sabatier of Toulouse1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
Major adverse cardiovascular events (MACE)

研究概览

简要总结

Aneurysmal or occlusive abdominal aortic pathology has seen its prevalence increase over the years despite the various cardiovascular risk factor management campaigns deployed.

Currently, a large proportion of these aortic pathologies require effective and definitive treatment by open surgery. In fact, minimally invasive endovascular treatment, which can provide good results in certain cases, cannot be generalized simply and can even lead to sometimes incomplete treatments requiring even more complex secondary open surgery.

The preoperative assessment before open aortic surgery is relatively well coded with cardiological and respiratory assessments in particular. However, the literature has so far never focused on the overall vision of the patient with a complete functional assessment which would make it possible to consider a specific preoperative fragility scale and would thus give practitioners corrective targets before such an intervention. in order to simplify the patient's post-operative journey by limiting complications.

The investigators therefore propose to collect a certain number of elements already collected in standard care in a systematic and prospective manner in order to create a risk scale. All of these elements being modifiable, they should ultimately make patients more robust for such an intervention.

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

入选标准

  • All patients undergoing open aortic surgery in the vascular surgery department

排除标准

  • patient refusal

结局指标

主要结局

Major adverse cardiovascular events (MACE)

时间窗: day 30 post operative

Rate of nonfatal stroke, nonfatal myocardial infarction and cardiovascular death

Home discharged

时间窗: day 30 post operative

Rate of patient who need a rehabilitation center after surgery

Length of stay

时间窗: day 30 post operative

Evaluation of the length of stay in days of the patients

Post operative mortality

时间窗: day 30 post operative

Rate of death after surgery

次要结局

  • Quality of life : Quality of Recovery-15(day 30, 3 months, 6 months, 1 year)
  • Quality of life : 36-item Short-Form Health Survey(day 30, 3 months, 6 months, 1 year)
  • Respiratory complications(day 30 post operative)

研究者

发起方
University Paul Sabatier of Toulouse
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aurélien Hostalrich

Clinical Professor

University Paul Sabatier of Toulouse

研究点 (1)

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