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Prospective Case-control Study in Patients With PAA

A Prospective Case-control Study of the Quality of Life in Patients With Aneurysmatic or Occlusive Disease in the Lower Limb

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04188808
Enrollment
130
Registered
2019-12-06
Start date
2018-09-01
Completion date
2028-12-31
Last updated
2022-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Arterial Disease, Popliteal Artery Aneurysm, Quality of Life

Keywords

Open vascular surgery, Vascular disease

Brief summary

The overall objective is to highlight different aspects of care in patients with PAA before and after treatment, and identifying factors that influence the outcome of PAA patients.

Detailed description

An aneurysm is most commonly defined as a permanent focal dilatation of an artery to 1.5 times its normal diameter. While the abdominal aorta is the most common site of aneurysm formation, the popliteal artery (PA) represents the second most common site of aneurysm formation, accounting for more than 70 percent of all peripheral aneurysms. A popliteal artery aneurysm (PAA) is a focal dilatation of the popliteal artery (red arrow). PAAs are rare in the general population but more commonly found in patient populations with other aneurysms, such as abdominal aortic aneurysm (AAA). Within the general population, PAAs are predominantly found in men and are extremely rare in women. There are few studies on the prevalence of PAAs in healthy individuals, but 14-19% of male and 12% of female AAA patients have PAAs. There is no clear correlation between the diameter of the AAA and the prevalence of PAA. There is furthermore a lack of consensus of the precise arterial diameter that defines a PAA. It is paramount to identify and treat PAA patients before acute symptoms develop, given the high risk of major complications associated with acute presentation, such as major amputation. Unfortunately, there is a lack of knowledge of the natural history for PAAs, which is why surgical procedures are recommended mainly based on clinical experience and guidelines developed from insufficient scientific information. The preventive purpose, more specifically to prevent the risk of acute symptom development, should be evaluated against the frequency of complications inflicted by surgical treatment, so called surgical risk. For this reason, it is important to evaluate the patients' health-related quality of life (HRQoL) before and after treatment in order to determine how the surgical treatment affect patients. In general, the Health-Related Quality of Life (HRQoL) is therefore emerging as an important outcome measure for interventions designed to improve patient's health, well-being, or both. There is very limited prior knowledge of HRQoL outcomes following surgical treatment of PAAs and the PAA patient's HRQoL, and whether-and to what extent- it becomes affected by the surgical treatment, is yet unknown. The surgical treatment in PAA patients and patients with peripheral arterial disease (PAD), are comparable whereas the underlying pathologies are distinct. Thus, peripheral arterial disease patients commonly experience substantial symptom relief following a surgical intervention (i.e. lower limb pain is alleviated, or ischemic wound healing is promoted). By contrast, PAA patients are often asymptomatic prior to surgery. It is therefore conceivable that a surgical intervention in PAA patients translates to a lower HRQoL after surgery than what is observed following bypass surgery for PAD. However, this needs to be further explored and confirmed in prospective studies. Aim To investigate whether the QoL of PAA patients compared to PAD patients after surgical and potential changes over time. Hypothesis Compared to PAD patients, femoropopliteal/femorodistal bypass surgery interventions undertaken on PAA patients result in a more pronounced negative HRQoL impact.

Interventions

All patients scheduled for elective surgery of PAA and PAD.

Sponsors

Karolinska University Hospital
CollaboratorOTHER
Karolinska Institutet
CollaboratorOTHER
Stockholm South General Hospital
CollaboratorOTHER
Sahlgrenska University Hospital
CollaboratorOTHER
Rebecka Hultgren
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
SF-36Five yearsA 36-item questionnaire that measures 8 dimensions of physical and mental health. ( 0-100) Positive if high

Secondary

MeasureTime frameDescription
EQ-5DFive yearsEQ-5D is a standardized instrument for measuring generic health status (0-100) 100 best Health and 0 worst helath

Other

MeasureTime frameDescription
PHQ-9 PHQ-9Five yearsDepressive symptoms were assessed with the validated nine-item. Patient Health Questionnaire. The PHQ provides a dichotomous measure of depressive symptoms ( 0- 30; below 4 = no deression; 10 or above = depression)

Countries

Sweden

Contacts

Primary ContactRebecka Hultgren, Prof
rebecka.hultgren@ki.se+46851776596
Backup ContactIva Jergovic, MD
iva.jergovic@sll.se+46851770947

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026