NCT06483516

Post-operative Quality of Life After AAA Management: EVAR Versus Open Repair

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: University Paul Sabatier of Toulouse · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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

Conditions

• Post Operative Quality of Life After AAA Surgery

Interventions

Type	Name	Description
PROCEDURE	Open repair	Open repair via median laparotomy or lumbotomy
PROCEDURE	Endovascular repair	EVAR if AAA simple F-BEVAR if Complex AAA

Timeline

• Start date: 2021-01-01
• Primary completion: 2021-01-03
• Completion: 2025-12-30
• First posted: 2024-07-03
• Last updated: 2024-07-03

Locations

1 site across 1 country: France