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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06201338
Acronym
Frail Aorta
Enrollment
200
Registered
2024-01-11
Start date
2023-11-15
Completion date
2025-12-01
Last updated
2024-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Aneurysm, Aortic Occlusion

Brief summary

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.

Interventions

PROCEDUREScreening of preoperative frailty

The day before the surgery, a multimodal evaluation is performed regarding : Cognitive assessment: Mini mental State evaluation (MMSE) test Physical functional assessment: Chair raising Addiction assessment: Fagerstrom Assessment of the social environment: environmental assessment Nutritional assessment: Grip test Quality of life: completion of SF 36 scale and QOR15 scale

Sponsors

Sarah BADICHE
CollaboratorUNKNOWN
University Paul Sabatier of Toulouse
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* patient refusal

Design outcomes

Primary

MeasureTime frameDescription
Post operative mortalityday 30 post operativeRate of death after surgery
Major adverse cardiovascular events (MACE)day 30 post operativeRate of nonfatal stroke, nonfatal myocardial infarction and cardiovascular death
Length of stayday 30 post operativeEvaluation of the length of stay in days of the patients
Home dischargedday 30 post operativeRate of patient who need a rehabilitation center after surgery

Secondary

MeasureTime frameDescription
Quality of life : 36-item Short-Form Health Surveyday 30, 3 months, 6 months, 1 yearEvaluation of post-operative quality of life compared to pre-operative data with 36-item Short-Form Health Survey
Quality of life : Quality of Recovery-15day 30, 3 months, 6 months, 1 yearEvaluation of post-operative quality of life compared to pre-operative data with Quality of life Quality of Recovery-15
Respiratory complicationsday 30 post operativeRate of pneumopathy and need of reintubation or intubation longer than 24h

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026