No registrations found.
ID
Source
Brief title
Health condition
Abdominal aortic aneurysm; intestinal ischaemia
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
Secondary outcome
Prolonged length of hospital stay
Background summary
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.
Study objective
The model will help reduce the mortality associated withintestinal ischaemia as a complication of AAA surgery.
Study design
Preparation
Intervention
AAA repair, open and endovascular
Inclusion criteria
- 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
Exclusion criteria
- 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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8053 |
| CCMO | NL70817.098.19 |