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NCT Number: NCT06483516

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aortic abdominal aneurysm above 50mm

Exclusion criteria

  • Emergent surgery

Treatment and study plan

Open Repair

Procedure

Open repair via median laparotomy or lumbotomy

Endovascular repair

Procedure

EVAR if AAA simple F-BEVAR if Complex AAA

Primary outcomes

  1. Quality of life evolution

    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

    Qor15 score filled by the patient

Secondary outcomes

  1. Post operative mortality

    Time frame: day 30

    Death after surgery

  2. early Reintervention

    Time frame: Day 30

    New operation

  3. late reintervention

    Time frame: 3 months, 6 months, yearly

    New operation

Sponsors and collaborators

Lead sponsor

University Paul Sabatier of Toulouse

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2025
First posted
Jul 3, 2024
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.