Complex Abdominal Aortic AneurysmsNCT07580443
Patient-Reported Quality of Life After Open Surgery for Complex Abdominal Aortic Aneurysms: A Prospective Study
An observational study of Complex Abdominal Aortic Aneurysms, run by Prouse Giorgio at 2 sites in Switzerland.
Trial summary
STUDY DURATION: January 2026 - December 2027 Each participant will be followed for 12 months postoperatively. BACKGROUND AND RATIONALE: Complex abdominal aortic aneurysms (cAAAs)-including juxtarenal, pararenal, and suprarenal aneurysms-can be treated via open surgical repair (OSR) or complex endovascular techniques… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complex Abdominal Aortic Aneurysms
- What is being tested?
- To assess changes in health-related quality of life (HRQoL) using the Short Form-36 (SF-36) questionnaire
- How many people
- 125 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 18 Mar 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be enrolled by the Department of Vascular Surgery in three different centres. Patients will be included if there is a diagnosis of complex abdominal aortic aneurysms (cAAAs), defined as juxtarenal, pararenal and suprarenal/paravisceral aneurysms. The study includes five time points for data collection: 1. Preoperative baseline (prior to surgery) 2. At hospital discharge (within 7 days after surgery) 3. 1 month postoperatively (± 1 weeks) 4. 6 months postoperatively (± 2 weeks) 5. 12 months postoperatively (± 4 weeks) At each of these time points, participants will complete the Short Form-36 (SF-36) Health Survey questionnaire to assess HRQOL, including physical and mental well-being.
Who may be able to join
- Patients over 18 years old
- Patients undergoing open surgical repair for complex abdominal aortic aneurysms (AAAs), including juxtarenal, pararenal and suprarenal/paravisceral aneurysms
- Patients treated for asymptomatic or symptomatic non ruptured aneurysms
- Patients who are able and willing to provide informed, complete, and accurate responses to the SF-36 questionnaire
Who cannot join
- Patients under 18 years old
- Patients treated for ruptured abdominal aortic aneurysms
- Patients with incomplete data, or who denied consent
- Patients with cognitive impairment or other conditions that prevent them from reliably completing the SF-36 questionnaires.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Elena Garbero, Msc. contact
Switzerland2 sites, 2 recruiting
- Not yet recruiting
Luzerner Kantonspital
Lucerne, 6004
Maani Hakimi, Prof., +41 041 205 48 88, maani.hakimi@luks.ch
Maani Hakimi, Prof.
- Recruiting
EOC - Ospedale Regionale di Lugano, Civico
Lugano, 6900
Elena Garbero, MSc., +41 091 811 63 28, elena.garbero@eoc.ch
Giorgio Prouse, MD
About this study
STUDY DURATION: January 2026 - December 2027 Each participant will be followed for 12 months postoperatively.
BACKGROUND AND RATIONALE: Complex abdominal aortic aneurysms (cAAAs)-including juxtarenal, pararenal, and suprarenal aneurysms-can be treated via open surgical repair (OSR) or complex endovascular techniques (f/bEVAR). While OSR may offer better long-term durability, especially in fit patients, there is currently a lack of data on patient-reported quality of life (QoL) outcomes following OSR for cAAAs. This study aims to fill this gap and support shared decision-making in vascular surgery.
Read more
OBJECTIVES:
- Primary Objective: To assess changes in health-related quality of life (HRQoL) using the Short Form-36 (SF-36) questionnaire at five predefined time points (baseline, discharge, 1 month, 6 months, and 12 months post-surgery).
- Secondary Objectives: To analyze QoL differences by patient subgroups (e.g., age, comorbidities, aneurysm type), to assess correlations with clinical outcomes (e.g., complications, hospital stay), and to evaluate the impact of postoperative complications on QoL.
STUDY POPULATION:
- Inclusion criteria: Adults (≥18 years) undergoing OSR for non-ruptured complex AAAs (juxtarenal, pararenal, suprarenal).
- Exclusion criteria: Patients under 18, those with ruptured AAAs, cognitive impairment, or those unable to complete the SF-36 questionnaire.
PARTICIPATING CENTERS:
- Ospedale Regionale di Lugano (EOC), Switzerland
- Luzerner Kantonsspital, Switzerland
- Centre Hospitalier Universitaire de Montpellier, France
STUDY PROCEDURES:
- Administration of the SF-36 questionnaire at five time points: preoperative, at discharge (within 7 days), and at 1, 6, and 12 months postoperatively.
- Data collection includes demographic information, aneurysm characteristics, in-hospital and follow-up outcomes, and questionnaire responses.
- Conditions
- Complex Abdominal Aortic Aneurysms
- Being tested
- To assess changes in health-related quality of life (HRQoL) using the Short Form-36 (SF-36) questionnaire
- Keywords
- Complex abdominal aortic aneurysms, SF-36, Quality of Life, Open surgical repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
To assess changes in health-related quality of life (HRQoL) using the Short Form-36 (SF-36) questionnaireOther
Patients enrolled in the study will perform the Short Form-36 Health Survey (SF-36) to assess quality of life at five different time points
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing open surgical repair for complex abdominal aortic aneuysms | Not described Receives: Other: To assess changes in health-related quality of life (HRQoL) using the Short Form-36 (SF-36) questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in health-related Quality of Life
The primary end point will be the analysis of change in health-related Quality of Life as measured by the SF-36 score between 5 time points.
Measured: preoperative (baseline), hospital discharge (within 1 week after surgery), 1 month after the procedure (± 1 weeks), 6 months after the procedure (± 2 weeks) and 1 year after the procedure (± 4 weeks).
Secondary outcomes (1)
QoL trajectory differences between subgroups
Secondary outcomes will include quality of life (QoL) trajectory differences between subgroups (e.g., age groups, comorbidity burden, aneurysm complexity), correlation between QoL outcomes and clinical variables (e.g., length of hospital stay, Intensive Care Unit (ICU) duration, postoperative complications), and incidence of postoperative complications and their impact on QoL
Measured: preoperative (baseline), hospital discharge (within 1 week after surgery), 1 month after the procedure, 6 months after the procedure and 1 year after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start18 Mar 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Abdominal Aortic AneurysmsStudies 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
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prouse Giorgio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prouse Giorgio, Ente Ospedaliero Cantonale, Bellinzona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07580443
- Sponsor's protocol ID
- 2025-01639
- Other IDs
- 2025
- Status last verified
- Sep 2026
- First submitted
- 5 May 2026
- Last updated
- 28 Sep 2026
- 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 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Reported Quality of Life After Open Surgery for Complex Abdominal Aortic Aneurysms: A Prospective Study
- ClinicalTrials.gov ID
- NCT07580443
- Acronym / sponsor ID
- 2025-01639
- Conditions
- Complex Abdominal Aortic Aneurysms
- Keywords
- Complex abdominal aortic aneurysms, SF-36, Quality of Life, Open surgical repair
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Prouse GiorgioUniversity, hospital or other
- Study start
- 18 Mar 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 May 2026 (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.
STUDY DURATION: January 2026 - December 2027 Each participant will be followed for 12 months postoperatively.
BACKGROUND AND RATIONALE: Complex abdominal aortic aneurysms (cAAAs)-including juxtarenal, pararenal, and suprarenal aneurysms-can be treated via open surgical repair (OSR) or complex endovascular techniques (f/bEVAR). While OSR may offer better long-term durability, especially in fit patients, there is currently a lack of data on patient-reported quality of life (QoL) outcomes following OSR for cAAAs. This study aims to fill this gap and support shared decision-making in vascular surgery.
OBJECTIVES:
- Primary Objective: To assess changes in health-related quality of life (HRQoL) using the Short Form-36 (SF-36) questionnaire at five predefined time points (baseline, discharge, 1 month, 6 months, and 12 months post-surgery).
- Secondary Objectives: To analyze QoL differences by patient subgroups (e.g., age, comorbidities, aneurysm type), to assess correlations with clinical outcomes (e.g., complications, hospital stay), and to evaluate the impact of postoperative complications on QoL.
STUDY POPULATION:
- Inclusion criteria: Adults (≥18 years) undergoing OSR for non-ruptured complex AAAs (juxtarenal, pararenal, suprarenal).
- Exclusion criteria: Patients under 18, those with ruptured AAAs, cognitive impairment, or those unable to complete the SF-36 questionnaire.
PARTICIPATING CENTERS:
- Ospedale Regionale di Lugano (EOC), Switzerland
- Luzerner Kantonsspital, Switzerland
- Centre Hospitalier Universitaire de Montpellier, France
STUDY PROCEDURES:
- Administration of the SF-36 questionnaire at five time points: preoperative, at discharge (within 7 days), and at 1, 6, and 12 months postoperatively.
- Data collection includes demographic information, aneurysm characteristics, in-hospital and follow-up outcomes, and questionnaire responses.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing open surgical repair for complex abdominal aortic aneuysms | – | Other: To assess changes in health-related quality of life (HRQoL) using the Short Form-36 (SF-36) questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be enrolled by the Department of Vascular Surgery in three different centres. Patients will be included if there is a diagnosis of complex abdominal aortic aneurysms (cAAAs), defined as juxtarenal, pararenal and suprarenal/paravisceral aneurysms. The study includes five time points for data collection: 1. Preoperative baseline (prior to surgery) 2. At hospital discharge (within 7 days after surgery) 3. 1 month postoperatively (± 1 weeks) 4. 6 months postoperatively (± 2 weeks) 5. 12 months postoperatively (± 4 weeks) At each of these time points, participants will complete the Short Form-36 (SF-36) Health Survey questionnaire to assess HRQOL, including physical and mental well-being.
Key inclusion criteria (4 listed)
- Patients over 18 years old
- Patients undergoing open surgical repair for complex abdominal aortic aneurysms (AAAs), including juxtarenal, pararenal and suprarenal/paravisceral aneurysms
- Patients treated for asymptomatic or symptomatic non ruptured aneurysms
- Patients who are able and willing to provide informed, complete, and accurate responses to the SF-36 questionnaire
Key exclusion criteria (4 listed)
- Patients under 18 years old
- Patients treated for ruptured abdominal aortic aneurysms
- Patients with incomplete data, or who denied consent
- Patients with cognitive impairment or other conditions that prevent them from reliably completing the SF-36 questionnaires.
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 |
|---|---|---|
| To assess changes in health-related quality of life (HRQoL) using the Short Form-36 (SF-36) questionnairePatients enrolled in the study will perform the Short Form-36 Health Survey (SF-36) to assess quality of life at five different time points | Other | Patients undergoing open surgical repair for complex abdominal aortic aneuysms |
Primary outcome
Change in health-related Quality of Life
Time frame: preoperative (baseline), hospital discharge (within 1 week after surgery), 1 month after the procedure (± 1 weeks), 6 months after the procedure (± 2 weeks) and 1 year after the procedure (± 4 weeks).
The primary end point will be the analysis of change in health-related Quality of Life as measured by the SF-36 score between 5 time points.
1 secondary outcome
QoL trajectory differences between subgroups
Time frame: preoperative (baseline), hospital discharge (within 1 week after surgery), 1 month after the procedure, 6 months after the procedure and 1 year after the procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- 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.
Elena Garbero, Msc. contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complex Abdominal Aortic Aneurysms, run by Prouse Giorgio at 2 sites in Switzerland.
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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giorgio Prouse, MD (+410918116328, giorgio.prouse@eoc.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in health-related Quality of Life (time frame: preoperative (baseline), hospital discharge (within 1 week after surgery), 1 month after the procedure (± 1 weeks), 6 months after the procedure (± 2 weeks) and 1 year after the procedure (± 4 weeks).). 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 28 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.