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

Aortic Aneurysm Clinical Trial

— Frail Aorta  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06201338
• Other study ID #: RnIPH 2023-91
• Status: Recruiting
• Start date: November 15, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: January 2024
• Source: University Paul Sabatier of Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• patient refusal

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm

Intervention

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

Locations

Country	Name	City	State
France	Toulouse university hospital, vascular surgery department	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
University Paul Sabatier of Toulouse	Sarah BADICHE

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post operative mortality	Rate of death after surgery	day 30 post operative
Primary	Major adverse cardiovascular events (MACE)	Rate of nonfatal stroke, nonfatal myocardial infarction and cardiovascular death	day 30 post operative
Primary	Length of stay	Evaluation of the length of stay in days of the patients	day 30 post operative
Primary	Home discharged	Rate of patient who need a rehabilitation center after surgery	day 30 post operative
Secondary	Respiratory complications	Rate of pneumopathy and need of reintubation or intubation longer than 24h	day 30 post operative
Secondary	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
Secondary	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