Pre-operative Screening of Functional Fragilities Before Open Aortic Surgery: a New Area (Frail Aorta)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Aneurysm; Aortic Occlusion
• Intervention / Treatment: Procedure: Screening of preoperative frailty

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31059
    • Recruiting
    • Toulouse university hospital, vascular surgery department
    • Contact: Aurélien Hostalrich, MD,PhD; Phone Number: 0033561322620; Email: hostalrich.a@chu-toulouse.fr
    • Principal Investigator: Sarah Badiche, MD
    • Principal Investigator: Virgile Pinelli, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• 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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• patient refusal

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Procedure: Screening 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory complications	Rate of pneumopathy and need of reintubation or intubation longer than 24h	day 30 post operative
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	day 30, 3 months, 6 months, 1 year
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	day 30, 3 months, 6 months, 1 year

Collaborators and Investigators

• Sponsor: University Paul Sabatier of Toulouse
• Collaborators: Sarah BADICHE

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2023
• Primary Completion (Actual): December 1, 2023
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: December 15, 2023
• First Submitted That Met QC Criteria: January 8, 2024
• First Posted (Actual): January 11, 2024

Study Record Updates

• Last Update Posted (Actual): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm
• Other Study ID Numbers: RnIPH 2023-91

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No