An observational study in Post Operative Quality of Life After AAA Surgery, sponsored by University Paul Sabatier of Toulouse. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-03.
Sponsored by University Paul Sabatier of Toulouse · Observational
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
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
University Paul Sabatier of Toulouse is the lead sponsor of 13 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient to be operated on for an aneurysm of the abdominal aorta in scheduled surgery
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patient operated for AAA by conventional surgery
Procedure: Open repair
Patient operated for AAA by Endovascular exclusion (EVAR/F-BEVAR)
Procedure: Endovascular repair
Open repair via median laparotomy or lumbotomy
EVAR if AAA simple F-BEVAR if Complex AAA
Quality of life evolution
Qor15 score filled by the patient
Time frame: 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
Post operative mortality
Death after surgery
Time frame: day 30
early Reintervention
New operation
Time frame: Day 30
late reintervention
New operation
Time frame: 3 months, 6 months, yearly
Plan to share: Undecided
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University Paul Sabatier of Toulouse