Evaluating care for patients with popliteal artery aneurysm
A Prospective Case-control Study of the Quality of Life in Patients With Aneurysmatic or Occlusive Disease in the Lower Limb
This study is trying to see how different types of care before and after surgery can affect the health and quality of life for people with popliteal artery aneurysms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Sex | All |
| Sponsor | Karolinska University Hospital Academic / other |
| Locations | 2 sites (Gothenburg and 1 other locations) |
| Trial ID | NCT04188808 on ClinicalTrials.gov |
What this trial studies
This study aims to assess various aspects of care for patients diagnosed with popliteal artery aneurysm (PAA) before and after surgical treatment. It focuses on identifying factors that influence patient outcomes and the natural history of PAAs, which are often under-researched. The study will involve patients scheduled for elective bypass surgery for PAA or peripheral arterial disease, collecting data on their health status and quality of life. By understanding these factors, the study seeks to improve treatment protocols and patient management.
Who should consider this trial
Good fit: Ideal candidates include patients scheduled for elective surgery for asymptomatic popliteal artery aneurysms or peripheral arterial disease.
Not a fit: Patients with cognitive impairments, major tissue loss, or severe pain may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and better quality of life for patients with popliteal artery aneurysms.
How similar studies have performed: While there is limited research specifically on PAAs, studies on similar vascular conditions have shown promising results in improving patient outcomes through surgical interventions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients scheduled for elective surgery of PAA (asymptomatic) * All patients scheduled for elective surgery of PAD * Elective open surgery * Intermittent claudication * Resting pain or very limited minor tissue loss Exclusion Criteria: * Cognitive failure * Major tissue loss * severe pain * if one cannot assimilate information in Swedish and understand the questionnaires
Where this trial is running
Gothenburg and 1 other locations
- Sahlgrenska University Hospital — Gothenburg, Sweden (Recruiting)
- Karolinska University Hospital — Stockholm, Sweden (Recruiting)
Study contacts
- Principal investigator: Rebecka Hultgren, Prof — Karolinska Instutet
- Study coordinator: Rebecka Hultgren, Prof
- Email: rebecka.hultgren@ki.se
- Phone: +46851776596
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.