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

NCT06201338 | Unknown DMC

• 1 other identifier: RnIPH 2023-91
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Aneurysm; Aortic Occlusion

Outcome Measures

Primary Outcomes (4)

• Post operative mortality

  Rate of death after surgery

  day 30 post operative

• Major adverse cardiovascular events (MACE)

  Rate of nonfatal stroke, nonfatal myocardial infarction and cardiovascular death

  day 30 post operative

• Length of stay

  Evaluation of the length of stay in days of the patients

  day 30 post operative

• Home discharged

  Rate of patient who need a rehabilitation center after surgery

  day 30 post operative

Secondary Outcomes (3)

• Respiratory complications

  day 30 post operative

• Quality of life : 36-item Short-Form Health Survey

  day 30, 3 months, 6 months, 1 year

• Quality of life : Quality of Recovery-15

  day 30, 3 months, 6 months, 1 year

Study Arms (1)

Open aortic surgery

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

Procedure: Screening of preoperative frailty

Interventions

Screening of preoperative frailty PROCEDURE

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

Open aortic surgery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• patient refusal

Sponsors & Collaborators

• University Paul Sabatier of Toulouse: lead
• Sarah BADICHE: collaborator

Study Sites (1)

Toulouse university hospital, vascular surgery department

Toulouse, 31059, France

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: January 11, 2024
• Study Start: November 15, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2025
• Last Updated: January 11, 2024

Record last verified: 2024-01

Locations

FR (1)