Clinical trial NCT05766579: Comparison Trial Between Elastic-compressive Stockings at 21 Versus 32 mmHg
Official title: ElaStic-compressive Stockings at 21 mmHg and 32 mmHg Following Thermal Ablation of the Great Saphenous Vein.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vascular Surgical Procedures
Keywords: Stockings, Compression
Thermoablation
Radiofrequency
Saphenous Vein
Lead sponsor: IRCCS Policlinico S. Donato
Sponsor class: OTHER
First posted: 2023-03-13
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Endovascular thermal ablation is currently considered as the best procedure for treating varicose veins thanks to its mini-invasiveness and the lowest rate of incidence of complications. At the end of the endovascular ablation procedure, the European Society of Vascular Surgery (ESVS) guidelines recommend the use of the compression stockings to reduce postoperative pain and the incidence of edema and thrombotic complications.

Despite this, the duration, type and degree of compression to be used, particularly after radiofrequency ablation procedures, remain a matter of debate. Furthermore, although the benefits of postoperative elastic compression therapy are well known, there is various evidence demonstrating how patients often experience poor comfort in wearing stockings, especially those with a higher degree of compression, which causes poor compliance with therapy. In light of all this, each center recommends the use of elastic compression stockings in the postoperative period with a degree of compression that varies, however, according to internal protocols.

There is currently no work in the literature that compares the advantages and disadvantages of using elastic compression stockings with a K2 versus K1 compression degree after radiofrequency ablative surgery.


Eligibility criteria: Inclusion Criteria:

* adult patients (\>18 years) suffering from varicose vein pathology of the lower limbs C2-3 class (varicose veins, edema) according to Clinic, Etiology, Anatomy, Pathophysiology (CEAP) classification, supported by incontinence of the great saphenous vein documented by Echo-Duplex study and candidates for thermal ablation by radiofrequency of the great vein saphenous vein with associated phlebectomy of the ipsilateral thigh and/or leg varices.

Exclusion Criteria:

* Patients who are minors (\< 18 years old) or adults who have not given their consent to participate in the study.
* Presence of severe obliterating arterial disease of the lower limbs (ABI \<0.5)
* Obesity (BMI \>30)
* Varicose pathology of the lower limbs in C4-C6 class according to Clinic, Etiology, Anatomy, Pathophysiology (CEAP) classification (presence of:

lipodermatosclerosis/eczema and/or ulcers in progress and/or previous ulcers in the affected lower limb).

* Pregnancy.

Primary outcomes:
measure: Postoperative Pain
timeFrame: 3 days after surgery
measure: Postoperative Pain
timeFrame: 7 days after surgery
Secondary outcomes:
measure: Lower limb edema
timeFrame: 3 days from intervention
measure: Lower limb edema
timeFrame: 7 days from intervention
measure: Lower limb edema
timeFrame: 30 days from intervention
measure: Analgesic Drugs Use
timeFrame: 3 days from intervention
measure: Analgesic Drugs Use
timeFrame: 7 days from intervention
measure: Analgesic Drugs Use
timeFrame: 30 days from intervention
measure: Discomfort
timeFrame: 3 days from intervention
measure: Discomfort
timeFrame: 7 days from intervention
measure: Discomfort
timeFrame: 30 days from intervention
measure: Postoperative Complications
timeFrame: 3 days from intervention
measure: Postoperative Complications
timeFrame: 7 days from intervention
measure: Postoperative Complications
timeFrame: 30 days from intervention
measure: Evaluation of Quality of Life
timeFrame: 3 days from intervention
measure: Evaluation of Quality of Life
timeFrame: 7 from intervention
measure: Evaluation of Quality of Life
timeFrame: 30 days from intervention
Other outcomes:
Locations:
city: San Donato Milanese
country: Italy
facility: I.R.C.C.S. Policlinico San Donato
state: Milan
Study officials:
References:
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