Clinical trial NCT06483516: Post-operative Quality of Life After AAA Management: EVAR Versus Open Repair
Official title: Post-operative Quality of Life After AAA Management: EVAR Versus Open Repair
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Post Operative Quality of Life After AAA Surgery
Lead sponsor: University Paul Sabatier of Toulouse
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient to be operated on for an aneurysm of the abdominal aorta in scheduled surgery

Brief summary: The treatment of AAA has been revolutionised by minimally invasive techniques that allow patients to return home more quickly and have a reputation for having a low impact on their quality of life.

However, no study has looked at the quality of life of patients treated for AAA using open or endovascular surgery, using a scale adapted to post-operative follow-up.

The investigators conducted a single-centre prospective observational study to assess the quality of life of patients undergoing AAA surgery by endovascular exclusion or open surgery

Detailed description: Aneurysms of the abdominal aorta are common in patients over the age of 65. Treatment methods to prevent rupture have changed considerably since the 2000s, with the advent of minimally invasive endovascular techniques. These minimally invasive techniques, which have the reputation of enabling patients to return home quickly without any loss of quality of life, have been called into question over time by the appearance of secondary endoleaks, leading to re-interventions and significant secondary ruptures.

Open aortic surgery is often described as invasive and burdensome for patients, with a lasting result in terms of efficacy in treating AAA, but at the cost of a major deterioration in patients' quality of life.

The literature presents numerous studies of postoperative quality of life, using general scales that have not been validated specifically for postoperative use. Furthermore, all these studies do not take into account the patient's pre-operative state and are therefore unable to provide an objective view of changes in quality of life and post-operative recovery after open surgery or evar. The QoR15 is a questionnaire comprising 15 questions specifically validated for the study of patients' early postoperative recovery.

In order to obtain objective data, the investigators conducted a single-centre prospective observational study to assess the quality of life of patients undergoing AAA surgery by endovascular exclusion or open surgery

Eligibility criteria: Inclusion Criteria:

* Aortic abdominal aneurysm above 50mm

Exclusion Criteria:

* Emergent surgery

Primary outcomes:
measure: Quality of life evolution
timeFrame: Day before surgery/ the day of discharge home (up to 1 month) / 1 month after surgery post operative consultation/ 6 months after surgery post operative consultation
Secondary outcomes:
measure: Post operative mortality
timeFrame: day 30
measure: early Reintervention
timeFrame: Day 30
measure: late reintervention
timeFrame: 3 months, 6 months, yearly
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Hostalrich
Study officials:
References: