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

Recruiting

• Conditions: Post Operative Quality of Life After AAA Surgery
• Interventions: Procedure: Open repair; Procedure: Endovascular repair

• Registration Number: NCT06483516
• Lead Sponsor: University Paul Sabatier of Toulouse

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

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2021-01-03
• Study First Submitted: 2024-06-21
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-01
• Last Update Submitted: 2024-07-01
• Study First Posted: 2024-07-03
• Last Update Posted: 2024-07-03
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Aortic abdominal aneurysm above 50mm

Exclusion Criteria

• Emergent surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OPEN REPAIR	Open repair	Patient operated for AAA by conventional surgery
ENDO REPAIR	Endovascular repair	Patient operated for AAA by Endovascular exclusion (EVAR/F-BEVAR)

Primary Outcome Measures

Name	Time	Method
Quality of life evolution	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	Qor15 score filled by the patient

Secondary Outcome Measures

Name	Time	Method
Post operative mortality	day 30	Death after surgery
late reintervention	3 months, 6 months, yearly	New operation
early Reintervention	Day 30	New operation

Trial Locations

Locations (1)

Hostalrich; 🇫🇷 Toulouse, France