Doppler Ultrasound Imaging of Plastic Surgery Patients for DVT Detection



Status:Recruiting
Conditions:Cardiology, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:9/12/2018
Start Date:January 2014
End Date:August 2022
Contact:Eric Swanson, M.D.
Email:eswanson@swansoncenter.com
Phone:913 663-1030

Use our guide to learn which trials are right for you!

Doppler Ultrasound Imaging of Plastic Surgery Patients for Deep Venous Thrombosis Detection: A Prospective Controlled Study.

This prospective controlled study examines the use of Doppler ultrasound as a means to screen
elective plastic surgery patients for the presence of deep venous blood clots both before and
after surgery. This is a noninvasive technique that is known to be both sensitive and
specific for the detection of deep venous thromboses in the lower extremities. This method
may make it unnecessary to select patients for prophylactic anticoagulation, which poses
additional risks to the patient.

Protocol

Investigation of Deep Venous Thromboses in Elective Cosmetic Surgery Patients using Doppler
Ultrasound

Background/Purpose

Venous thromboembolism is a well-known and serious risk of surgery. In an attempt to reduce
the frequency of this postoperative complication, many plastic surgeons today elect to
anticoagulate patients deemed to be at higher risk.1 The efficacy and ethics of this
treatment have been challenged.2 Moreover, prophylactic anticoagulation poses additional
serious risks of its own, including increased bleeding and wound hematomas.2 It makes sense
to use a screening device to detect not just symptomatic cases but also subclinical deep
venous thrombosis so that treatment can be promptly initiated and patients without evidence
of blood clots can be spared the needless side effects of anticoagulation.

Doppler ultrasound imaging represents a sensitive, direct, and noninvasive method to screen
for the presence of venous thromboses.3 This prospective study is undertaken to determine its
feasibility in the setting of outpatient plastic surgery. Doppler ultrasound imaging as a
screening tool for elective plastic surgery patients has not been previously published. This
test is added to the perioperative protocol, which is otherwise unchanged.

Subjects

Two hundred consecutive consenting adult men and women undergoing outpatient elective plastic
surgery under total intravenous anesthesia will be investigated using Doppler ultrasound
scans preoperatively, on the first day after surgery, and approximately 1 week after surgery.
Common operations included liposuction, abdominoplasty, facelifts, and cosmetic breast
surgery. In addition, 25 control patients (i.e., men and women not having surgery) will be
investigated at the same intervals.

Scans

The Terason t3200 Ultrasound System Vascular series images the deep veins of both lower
extremities. The veins evaluated with this imaging technique consist of the common femoral,
greater saphenous, superficial femoral, popliteal, and posterior tibial veins. Both color
Doppler flow and 2-dimensional compression tests (Duplex scans) are performed. The thickness
of the adipose layer is also measured and patient weights are recorded to check for any
possible correlations.

Clinical measures to reduce the risk of venous thrombosis include: (1) spontaneous breathing
without muscle relaxants, (2) no prone positioning in surgery, (4) sequential compression
devices, (4) movement of the lower extremities during surgery, and (5) outpatient treatment
with early ambulation.2

Patients are cautioned that deep venous thrombosis (blood clots) are a known risk of surgery
and that they are to report any asymmetrical swelling of the lower extremities, thigh pain,
or fever to their surgeon immediately. Any patient with a positive scan is referred to a
local hospital for confirmation and treatment.

Null Hypothesis

Ultrasound scans are a safe, noninvasive, effective method to detect blood clots in the deep
veins of the lower extremities in plastic surgical patients.

Informed Consent

Patients are informed as to the nature of the study and are told that their participation is
entirely voluntary and they are free to decline, and that doing so does not in any way
prejudice their treatment.

Patient Risk

There is no patient risk. The study does not affect patient treatment. It offers the
possibility of detection of sub-clinical deep venous thrombosis.

Sample Size

A sample of 2000 treated patients and 25 controls is anticipated.

Disclosure

The author has no financial interest in any of the products, devices, or drugs mentioned in
this article. The author has no conflicts of interest to disclose. There was no outside
funding for this study.

Inclusion Criteria:

- elective plastic surgery patient

- consenting patient

Exclusion Criteria:

- no consent
We found this trial at
1
site
Leawood, Kansas 66211
Principal Investigator: Eric Swanson, M.D.
Phone: 913-663-1030
?
mi
from
Leawood, KS
Click here to add this to my saved trials