QoL After Complex Endovascular Aortic Repair

Quality of Life Clinical Trial

Official title: QoL After Complex Endovascular Aortic Repair

Status Recruiting

Clinical Trial 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 question 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-stnadard 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).

Clinical Trial Description

Prospective cohort study with patients planned for elective aortic endovascular repair during a twoyear 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 aneurysmrelated 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.

We 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-stnadard 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 decicion 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. ;

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Quality of Life

• NCT number: NCT05774938
• Study type: Observational
• Source: Karolinska University Hospital
• Contact: Rebecka Hultgren, MD, PhD
• Phone: +46 8 123 700 00
• Email: rebecka.hultgren@ki.se
• Status: Recruiting
• Start date: February 28, 2023
• Completion date: January 2030