Patient-Reported Quality of Life After Open Surgery for Complex Abdominal Aortic Aneurysms: A Prospective Study
13. maj 2026 opdateret af: 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.
Studieoversigt
Status
Rekruttering
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Anslået)
125
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Giorgio Prouse, MD
- Telefonnummer: +410918116328
- E-mail: giorgio.prouse@eoc.ch
Undersøgelse Kontakt Backup
- Navn: Elena Garbero, Msc.
- E-mail: elena.garbero@eoc.ch
Studiesteder
-
-
-
Lucerne, Schweiz, 6004
- Ikke rekrutterer endnu
- Luzerner Kantonspital
-
Kontakt:
- Maani Hakimi, Prof.
- Telefonnummer: +41 041 205 48 88
- E-mail: maani.hakimi@luks.ch
-
Ledende efterforsker:
- Maani Hakimi, Prof.
-
Lugano, Schweiz, 6900
- Rekruttering
- EOC - Ospedale Regionale di Lugano, Civico
-
Kontakt:
- Elena Garbero, MSc.
- Telefonnummer: +41 091 811 63 28
- E-mail: elena.garbero@eoc.ch
-
Ledende efterforsker:
- Giorgio Prouse, MD
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / 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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
18. marts 2026
Primær færdiggørelse (Anslået)
31. december 2027
Studieafslutning (Anslået)
31. december 2027
Datoer for studieregistrering
Først indsendt
5. maj 2026
Først indsendt, der opfyldte QC-kriterier
5. maj 2026
Først opslået (Faktiske)
12. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
15. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2025-01639
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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