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

NCT ID: NCT06201338

Last Updated: 2024-01-11

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-15
• Study Completion Date: 2025-12-01

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Open aortic surgery

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

Screening of preoperative frailty

Intervention Type: 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

Interventions

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• patient refusal

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sarah BADICHE

UNKNOWN

Sponsor Role: collaborator

University Paul Sabatier of Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Aurélien Hostalrich

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Toulouse university hospital, vascular surgery department

Toulouse, , France

Site Status: RECRUITING

Countries

France

Facility Contacts

Aurélien Hostalrich, MD,PhD

Role: primary

hostalrich.a@chu-toulouse.fr

0033561322620

Other Identifiers

RnIPH 2023-91

Identifier Type: -

Identifier Source: org_study_id