The model will help reduce the mortality associated withintestinal ischaemia as a complication of AAA surgery.
ID
Bron
Verkorte titel
Aandoening
Abdominal aortic aneurysm; intestinal ischaemia
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
o To assess if our model is accurate in the prediction of postoperative intestinal ischemia.
High predictive scores in patients who develop clinical signs of intestinal ischemia
Higher/rising serum D-dimer, procalcitonin and IFABP levels in patients who develop clinical signs of intestinal ischemia
o The practicability and feasibility of the model in the clinical practice
Usefulness according to vascular surgeons
o Postoperative mortality based on intestinal ischemia
Mortality in study population compared to usual postoperative mortality numbers
Achtergrond van het onderzoek
Rationale: Intestinal ischemia is a rare, yet dreaded complication after surgical repair of an abdominal aortic aneurysm (AAA).
Objective: The main objective is to assess if our model, consisting of patient-related and procedure-related factors, complemented/together with measurements of serum D-dimer, procalcitonin and IFABP levels is accurate in the prediction of postoperative intestinal ischemia in patients undergoing both elective and acute aneurysm surgery.
Study design: Prospective observational cohort study
Study population: Patients of the Haga Hospital in which surgery of an abdominal aortic aneurysm should take place, 18-90 years old.
Main study parameters/endpoints:
- To assess if our model is accurate in the prediction of postoperative intestinal ischemia.
o High predictive scores in patients who develop clinical signs of intestinal ischemia
o Higher/rising serum D-dimer, procalcitonin and IFABP levels in patients who develop clinical signs of intestinal ischemia
- The practicability and feasibility of the model in the clinical practice
- Postoperative mortality based on intestinal ischemia
Secondary study parameters/endpoints: Prolonged length of hospital stay
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Extra blood samples will be taken, a maximum of 2-3 times. The estimated risk associated with venapuncture is low.
Doel van het onderzoek
The model will help reduce the mortality associated withintestinal ischaemia as a complication of AAA surgery.
Onderzoeksopzet
Preparation
Onderzoeksproduct en/of interventie
AAA repair, open and endovascular
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Adult patient, from eighteen up to ninety years old with an abdominal aortic aneurysm, admitted to the hospital for surgical correction of the aneurysm.
- Atherosclerotic aethiology of the AAA
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Aethiology other than atherosclerotic disease
- Age ninety years or above
- Patients unable to give informed consent
- Patients with a history of intestinal ischemia
- Patients with active malignancies
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8053 |
| CCMO | NL70817.098.19 |