Prospective Case-control Study in Patients With PAA

  • STATUS
    Recruiting
  • End date
    Dec 3, 2028
  • participants needed
    130
  • sponsor
    Rebecka Hultgren
Updated on 20 February 2022
intermittent claudication

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.

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.

Details
Condition Popliteal Artery Aneurysm, Peripheral Arterial Disease, Quality of Life
Treatment Bypass surgery
Clinical Study IdentifierNCT04188808
SponsorRebecka Hultgren
Last Modified on20 February 2022

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note