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

NCT ID: NCT06483516

Last Updated: 2024-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2025-12-30

Brief Summary

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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

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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

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Post Operative Quality of Life After AAA Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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OPEN REPAIR

Patient operated for AAA by conventional surgery

Open repair

Intervention Type PROCEDURE

Open repair via median laparotomy or lumbotomy

ENDO REPAIR

Patient operated for AAA by Endovascular exclusion (EVAR/F-BEVAR)

Endovascular repair

Intervention Type PROCEDURE

EVAR if AAA simple F-BEVAR if Complex AAA

Interventions

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Open repair

Open repair via median laparotomy or lumbotomy

Intervention Type PROCEDURE

Endovascular repair

EVAR if AAA simple F-BEVAR if Complex AAA

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Aortic abdominal aneurysm above 50mm

Exclusion Criteria

* Emergent surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Paul Sabatier of Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Aurélien Hostalrich

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hostalrich

Toulouse, , France

Site Status RECRUITING

Countries

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France

Facility Contacts

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AURELIEN HOSTALRICH

Role: primary

0673303969

AURELIEN HOSTALRICH

Role: backup

Other Identifiers

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QOL AAA

Identifier Type: -

Identifier Source: org_study_id

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