Post Operative Quality of Life After AAA SurgeryNCT06483516
Post-operative Quality of Life After AAA Management: EVAR Versus Open Repair
An observational study of Post Operative Quality of Life After AAA Surgery, run by University Paul Sabatier of Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Operative Quality of Life After AAA Surgery
- What is being tested?
- Open repair and Endovascular repair
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2021to 30 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patient to be operated on for an aneurysm of the abdominal aorta in scheduled surgery
Who may be able to join
- Aortic abdominal aneurysm above 50mm
Who cannot join
- Emergent surgery
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hostalrich
Toulouse, 31400
AURELIEN HOSTALRICH, 0673303969, aurelien.hos@gmail.com
AURELIEN HOSTALRICH, aurelien.hos@gmail.com
About this study
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
Read the 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
- Being tested
- Open repair, Endovascular repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open repairProcedure or surgery
Open repair via median laparotomy or lumbotomy
Endovascular repairProcedure or surgery
EVAR if AAA simple F-BEVAR if Complex AAA
| Study group | Role | What they receive |
|---|---|---|
| OPEN REPAIR | Patient operated for AAA by conventional surgery Receives: Procedure: Open repair | |
| ENDO REPAIR | Patient operated for AAA by Endovascular exclusion (EVAR/F-BEVAR) Receives: Procedure: Endovascular repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life evolution
Qor15 score filled by the patient
Measured: 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
Secondary outcomes (3)
Post operative mortality
Death after surgery
Measured: day 30
early Reintervention
New operation
Measured: Day 30
late reintervention
New operation
Measured: 3 months, 6 months, yearly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Jan 2021
- Primary completion3 Jan 2021
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative Quality of Life After AAA SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Paul Sabatier of Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aurélien Hostalrich, University Paul Sabatier of Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06483516
- Sponsor's protocol ID
- QOL AAA
- Status last verified
- Jul 2024
- First submitted
- 21 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-operative Quality of Life After AAA Management: EVAR Versus Open Repair
- ClinicalTrials.gov ID
- NCT06483516
- Acronym / sponsor ID
- QOL AAA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Paul Sabatier of ToulouseUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 3 Jan 2021 (actual)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OPEN REPAIR | – | Procedure: Open repairPatient operated for AAA by conventional surgery |
| ENDO REPAIR | – | Procedure: Endovascular repairPatient operated for AAA by Endovascular exclusion (EVAR/F-BEVAR) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient to be operated on for an aneurysm of the abdominal aorta in scheduled surgery
Key inclusion criteria (1 listed)
- Aortic abdominal aneurysm above 50mm
Key exclusion criteria (1 listed)
- Emergent surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open repairOpen repair via median laparotomy or lumbotomy | Procedure or surgery | OPEN REPAIR |
| Endovascular repairEVAR if AAA simple F-BEVAR if Complex AAA | Procedure or surgery | ENDO REPAIR |
Primary outcome
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
3 secondary outcomes
Post operative mortality
Time frame: day 30
early Reintervention
Time frame: Day 30
late reintervention
Time frame: 3 months, 6 months, yearly
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Operative Quality of Life After AAA Surgery, run by University Paul Sabatier of Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.