Patient-Reported Quality of Life After Open Surgery for Complex Abdominal Aortic Aneurysms: A Prospective Study
13. mai 2026 oppdatert av: Prouse Giorgio
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.
Studieoversikt
Status
Rekruttering
Studietype
Observasjonsmessig
Registrering (Antatt)
125
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Giorgio Prouse, MD
- Telefonnummer: +410918116328
- E-post: giorgio.prouse@eoc.ch
Studer Kontakt Backup
- Navn: Elena Garbero, Msc.
- E-post: elena.garbero@eoc.ch
Studiesteder
-
-
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Lucerne, Sveits, 6004
- Har ikke rekruttert ennå
- Luzerner Kantonspital
-
Ta kontakt med:
- Maani Hakimi, Prof.
- Telefonnummer: +41 041 205 48 88
- E-post: maani.hakimi@luks.ch
-
Hovedetterforsker:
- Maani Hakimi, Prof.
-
Lugano, Sveits, 6900
- Rekruttering
- EOC - Ospedale Regionale di Lugano, Civico
-
Ta kontakt med:
- Elena Garbero, MSc.
- Telefonnummer: +41 091 811 63 28
- E-post: elena.garbero@eoc.ch
-
Hovedetterforsker:
- Giorgio Prouse, MD
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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:
- Preoperative baseline (prior to surgery)
- At hospital discharge (within 7 days after surgery)
- 1 month postoperatively
- 6 months postoperatively
- 12 months postoperatively 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.
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Patients undergoing open surgical repair for complex abdominal aortic aneuysms
|
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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in health-related Quality of Life
Tidsramme: 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.
|
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.
|
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.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
QoL trajectory differences between subgroups
Tidsramme: 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.
|
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
|
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.
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
18. mars 2026
Primær fullføring (Antatt)
31. desember 2027
Studiet fullført (Antatt)
31. desember 2027
Datoer for studieregistrering
Først innsendt
5. mai 2026
Først innsendt som oppfylte QC-kriteriene
5. mai 2026
Først lagt ut (Faktiske)
12. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
15. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
13. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2025-01639
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
UBESLUTTE
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