Aortic AneurysmFrail AortaNCT06201338
Pre-operative Screening of Functional Fragilities Before Open Aortic Surgery: a New Area
An observational study of Aortic Aneurysm and Aortic Occlusion, run by University Paul Sabatier of Toulouse at 1 site in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Aneurysm, Aortic Occlusion
- What is being tested?
- Screening of preoperative frailty
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 15 Nov 2023to 1 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: * Aortic aneurysm >55mm * Aortic occlusion responsible for severe claudication of the lower limbs or critical ischemia
Who may be able to join
- All patients undergoing open aortic surgery in the vascular surgery department
Who cannot join
- patient refusal
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Toulouse university hospital, vascular surgery department
Toulouse, 31059
Aurélien Hostalrich, MD,PhD, 0033561322620, hostalrich.a@chu-toulouse.fr
Sarah Badiche, MD
About this study
Official title: 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.
Read more
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
- Being tested
- Screening of preoperative frailty
- Medical subject headings
- Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening of preoperative frailtyProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Open aortic surgery | Patient undergoing open surgery for abdominal aortic aneurysm or abdominal aortic occlusion Receives: Procedure: Screening of preoperative frailty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative mortality
Rate of death after surgery
Measured: day 30 post operative
Major adverse cardiovascular events (MACE)
Rate of nonfatal stroke, nonfatal myocardial infarction and cardiovascular death
Measured: day 30 post operative
Length of stay
Evaluation of the length of stay in days of the patients
Measured: day 30 post operative
Home discharged
Rate of patient who need a rehabilitation center after surgery
Measured: day 30 post operative
Secondary outcomes (3)
Respiratory complications
Rate of pneumopathy and need of reintubation or intubation longer than 24h
Measured: 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
Measured: 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
Measured: day 30, 3 months, 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start15 Nov 2023
- Primary completion1 Dec 2023
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Paul Sabatier of Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- Sarah BADICHE
- Responsible party
- Principal investigator, Aurélien Hostalrich, University Paul Sabatier of Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06201338
- Sponsor's protocol ID
- RnIPH 2023-91
- Acronym
- Frail Aorta
- Status last verified
- Jan 2024
- First submitted
- 15 Dec 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-operative Screening of Functional Fragilities Before Open Aortic Surgery : a New Area
- ClinicalTrials.gov ID
- NCT06201338
- Acronym / sponsor ID
- Frail Aorta / RnIPH 2023-91
- Conditions
- Aortic Aneurysm, Aortic Occlusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Paul Sabatier of ToulouseUniversity, hospital or other
- Collaborators
- Sarah BADICHE
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 11 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open aortic surgery | – | Procedure: Screening of preoperative frailtyPatient undergoing open surgery for abdominal aortic aneurysm or abdominal aortic occlusion |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- * Aortic aneurysm >55mm * Aortic occlusion responsible for severe claudication of the lower limbs or critical ischemia
Key inclusion criteria (1 listed)
- All patients undergoing open aortic surgery in the vascular surgery department
Key exclusion criteria (1 listed)
- patient refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening of preoperative frailtyThe 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 | Procedure or surgery | Open aortic surgery |
Primary outcome
Post operative mortality
Time frame: day 30 post operative
Rate of death after surgery
Major adverse cardiovascular events (MACE)
Time frame: day 30 post operative
Rate of nonfatal stroke, nonfatal myocardial infarction and cardiovascular death
Length of stay
Time frame: day 30 post operative
Evaluation of the length of stay in days of the patients
Home discharged
Time frame: day 30 post operative
Rate of patient who need a rehabilitation center after surgery
3 secondary outcomes
Respiratory complications
Time frame: day 30 post operative
Quality of life : 36-item Short-Form Health Survey
Time frame: day 30, 3 months, 6 months, 1 year
Quality of life : Quality of Recovery-15
Time frame: day 30, 3 months, 6 months, 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Toulouse university hospital, vascular surgery department
Toulouse, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Aneurysm and Aortic Occlusion, run by University Paul Sabatier of Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative mortality (time frame: day 30 post operative). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.