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RecruitingNCT06201338Frail AortaUpdated Jan 11, 2024

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

An observational study in Aortic Aneurysm and Aortic Occlusion, sponsored by University Paul Sabatier of Toulouse. Recruiting at 1 site in France. Per ClinicalTrials.gov, last updated 2024-01-11.

Sponsored by University Paul Sabatier of Toulouse · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Sex
All
01

Study 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.

02

Conditions studied

  • Aortic Aneurysm
  • Aortic Occlusion

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03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

  • Aortic aneurysm >55mm
  • Aortic occlusion responsible for severe claudication of the lower limbs or critical ischemia

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • patient refusal
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • Open aortic surgery

    Patient undergoing open surgery for abdominal aortic aneurysm or abdominal aortic occlusion

    Procedure: Screening of preoperative frailty

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

05

What researchers measure

Primary outcomes

  1. Post operative mortality

    Rate of death after surgery

    Time frame: day 30 post operative

  2. Major adverse cardiovascular events (MACE)

    Rate of nonfatal stroke, nonfatal myocardial infarction and cardiovascular death

    Time frame: day 30 post operative

  3. Length of stay

    Evaluation of the length of stay in days of the patients

    Time frame: day 30 post operative

  4. Home discharged

    Rate of patient who need a rehabilitation center after surgery

    Time frame: day 30 post operative

Secondary outcomes

  1. Respiratory complications

    Rate of pneumopathy and need of reintubation or intubation longer than 24h

    Time frame: day 30 post operative

  2. Quality of life : 36-item Short-Form Health Survey

    Evaluation of post-operative quality of life compared to pre-operative data with 36-item Short-Form Health Survey

    Time frame: day 30, 3 months, 6 months, 1 year

  3. Quality of life : Quality of Recovery-15

    Evaluation of post-operative quality of life compared to pre-operative data with Quality of life Quality of Recovery-15

    Time frame: day 30, 3 months, 6 months, 1 year

06

Study locations

1 of 1 sites recruiting
  • Toulouse university hospital, vascular surgery department
    Toulouse, 31059, France
    • Aurélien Hostalrich, MD,PhD · Contact · hostalrich.a@chu-toulouse.fr · 0033561322620
    • Sarah Badiche, MD · Principal investigator
    • Virgile Pinelli, MD · Principal investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06201338
Lead sponsor
University Paul Sabatier of Toulouse
Collaborators
Sarah BADICHE
Responsible party
Aurélien Hostalrich (Clinical Professor, University Paul Sabatier of Toulouse) — Principal investigator
First posted
Jan 11, 2024
Start date
Nov 15, 2023
Primary completion
Dec 1, 2023
Completion
Dec 1, 2025 (estimated)
Last update
Jan 11, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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