Ignite Creation Date:
2024-07-17 @ 11:02 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06483516
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-21
Brief Title:
Post-operative Quality of Life After AAA Management EVAR Versus Open Repair
Sponsor:
University Paul Sabatier of Toulouse
Organization:
University Paul Sabatier of Toulouse
Study Overview
Official Title:
Post-operative Quality of Life After AAA Management EVAR Versus Open Repair
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 patients 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
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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None