Clinical trial NCT03703765: Volume Estimation of the Limb After VEnous Treatment
Official title: Volume Estimation of Lower Limbs Before and After Endovascular Venous Intervention or Conventional Surgery in Venous Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Disease
Keywords: Volume
veins
lower limb
imaging
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2018-10-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Chronic venous disease encompasses a broad spectrum of clinical presentations and is considered the most common vascular disease. Its causes are diverse, including primary defects of the wall or valves, chronic venous insufficiency, or lesions secondary to thrombosis, a post-thrombotic venous disease, affecting the superficial or deep venous network or both. The major symptom of venous disease is the enlargement of the lower limbs, which can result in edema. The evaluation of the volume of the lower limbs is very important in the diagnosis and follow-up of the venous pathology. There is a great variability of clinical pictures making it difficult to choose the therapeutic gesture. Endovascular venous interventions and conventional venous surgery are major advances in the treatment of venous disease. The variation of lower limb volume in pre and post procedure is a determining factor; thus orienting clinicians for post interventional therapeutic monitoring. Indeed the management of venous disease is multidisciplinary, it involves the cooperation of several specialists as part of its monitoring and its therapeutic management. Our collaborative group includes the Adult and Child Vascular Investigations Department, the Vascular Clinic, the Cardiovascular and Thoracic Surgery Department, and the Interventional Radiology Department. The evaluation of the variation of the volumes of the lower limbs is a capital data for the various specialists for the care in pre and post procedure. A volumetric 3D scanner system guarantees a reliable measurement ensuring optimal evolution and therapeutic follow-up.

Detailed description: At admission eligible patients are proposed to participate. Written consent is signed after complete oral and written explanation of the protocol is signed. No register of non-included patients will be kept.

In included patients, in parallel to the routine ultrasound investigation for which the patient is referred, the evaluation of the variation of the volumes of the lower limbs with the volumetric 3D scanner will be performed as explained later in arm description.

Usual ongoing treatments are obtained by history and recorded. The end of the visit is the end of the participation of the subjects.

Eligibility criteria: Inclusion Criteria:

* subjects referred for investigation of a preoperative venous assessment
* affiliation to the French National healthcare system
* french speaking patients

Exclusion Criteria:

* pregnancy
* inability to understand the study goal
* patients protected by decision of law

Primary outcomes:
measure: Volume of lower limbs
timeFrame: 12 months
Secondary outcomes:
measure: Change in symptoms and quality of life
timeFrame: 12 months
measure: Change in symptoms and quality of life
timeFrame: 12 months
measure: Change in symptoms and quality of life
timeFrame: 12 months
measure: Change in symptoms and quality of life
timeFrame: 12 months
measure: Validity
timeFrame: 1 hour
Other outcomes:
Locations:
city: Angers
country: France
facility: UH Angers
Study officials:
affiliation: University Hospital, Angers
name: HENNI MD SAMIR, PhD
role: PRINCIPAL_INVESTIGATOR
References: