Clinical trial NCT05774938: QoL After Complex Endovascular Aortic Repair
Official title: QoL After Complex Endovascular Aortic Repair
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Quality of Life
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Keywords: Endovascular aneurysm repair
Pararenal aortic aneurysm
Quality of life
Paravisceral aortic aneurysm
Fenestrated endovascular aortic repair
Branched endovascular aortic repair
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2023-03-20
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with infrarenal or paravisceral aortic aneurysms planned for treatment with EVAR or F-/BEVAR will be invited to participate in the study at the time of consent of the proposed treatment

Brief summary: The goal of this prospective observational cohort study is to compare health related quality of life in patients with abdominal aortic aneurysms treated by either standard or complex EVAR (endovascular aneurysm repair) devices. The main questions it aims to answer are:

* Compare differences between the physical scores from the preoperative to the postoperative settings between patients treated with standard EVAR vs non-standard endovascular aortic repair (F-/BEVAR)
* To compare long-term physical scores postoperatively between patients treated with standard EVAR vs non-standard endovascular aortic repair (F-/BEVAR) at one year.
* To explore at which time points (if ever) patients treated with standard-EVAR and nonstandard endovascular aortic repair (F-/BEVAR) have restored or normalized physical scores measured by SF-12, measured at 30 days, 6 months, 1 and 3 years.

Participants will be asked to fill out forms pre- and postoperatively with regards to health related quality of life.

The different groups for comparison will be either standard EVAR for infrarenal aortic aneurysms or complex EVAR (fenestrated or branched) for paravisceral aortic aneurysms (PVAAA).

Detailed description: Prospective cohort study with patients planned for elective aortic endovascular repair during a two year time period. The estimated recruitment period is February 2023 - February 2025.

All patients with infrarenal or paravisceral aortic aneurysms planned for treatment with EVAR or F-/BEVAR will be invited to participate in the study at the time of consent of the proposed treatment.

The questionnaires to be filled out will be available online or by paper form. Patient- and aneurysm related variables will be recorded at the time of treatment decision. The endpoint is 3 years of follow up or death. Analysis will be done by both intention-to-treat and per protocol.

The questionnaires to be used are:

* SF-12
* EQ5D
* HADS
* Custom made questionnaire: Education, marital status and need for domestic service

The forms will be filled out at the following intervals:

* Preoperatively (\<90 days prior to surgery).
* 30 days postoperatively.
* 6 months postoperatively.
* 12 months postoperatively.
* 36 months postoperatively.

The investigators aim to answer the following research questions:

* Compare differences between the physical scores from the preoperative to the postoperative settings between patients treated with standard EVAR vs non-standard endovascular aortic repair (F-/BEVAR)
* To compare long-term physical scores postoperatively between patients treated with standard EVAR vs non-standard endovascular aortic repair (F-/BEVAR) at one year.
* To explore at which time points (if ever) patients treated with standard-EVAR and nonstandard endovascular aortic repair (F-/BEVAR) have restored or normalized physical scores measured by SF-12, measured at 30 days, 6 months, 1 and 3 years.
* To compare mental scores in SF-12 and HADS postoperatively compared to preoperatively between patients treated with standard EVAR vs non-standard endovascular aortic repair (F-/BEVAR).
* To compare long-term mental scores and HADS-A and HADS-D postoperatively between patients treated with standard EVAR vs non-standard endovascular aortic repair (F-/BEVAR) at one year and three years.
* To evaluate if a decreased function of physical and mental scores in EQ5D or SF-12 should be considered in a preoperative decision model by considering QALYs.
* To compare preoperative physical and mental scores by SF-12 and HADS-A / HADS-D between standard EVAR vs non-standard endovascular aortic repair (F-/BEVAR).
* To compare preoperative and postoperative physical and mental scores by SF-12 and HADS-A / HADS-D between standard EVAR vs de-novo non-standard endovascular aortic repair (F-/BEVAR) vs F-/BEVAR in a previously treated EVAR patient.

Eligibility criteria: Inclusion Criteria:

* Men and women.
* Any age (≥18 years)
* Planned (elective) endovascular treatment by EVAR, FEVAR or BEVAR.
* Patients previously treated by EVAR which are planned for an adjunct fenestrated cuff will not be included in the basic analysis, but included and analysed separately.

Exclusion Criteria:

* Inability to understand and/or respond to the study questionnaires that are in Swedish.
* Inability to provide an informed consent for participation in the study, orally or in writing (This may be due to linguistic or cognitive limitation).
* Participation in other ongoing studies concerning quality of life.

Primary outcomes:
measure: Early physical component score changes after standard or complex EVAR procedure.
timeFrame: 2026
Secondary outcomes:
measure: Late physical component score changes after standard or complex EVAR procedure.
timeFrame: 2026
measure: When does physical component scores return to normal after standard or complex EVAR procedures?
timeFrame: 2028
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
References: