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NCT Number: NCT05766579

Comparison Trial Between Elastic-compressive Stockings at 21 Versus 32 mmHg

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.

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Key information

Conditions

Vascular Surgical Procedures

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

I.R.C.C.S. Policlinico San Donato

San Donato Milanese, Milan, 20097, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Elastic-compressive stockings

Device

Use of Elastic-compressive stockings at 21 mmHg and 32 mmHg.

Primary outcomes

  1. Postoperative Pain

    Time frame: 3 days after surgery

    Evaluation of postoperative pain using the Visual Analogic pain Scale (1-10, being higher the pain the higher the value of the scale)

  2. Postoperative Pain

    Time frame: 7 days after surgery

    Evaluation of postoperative pain using the Visual Analogic pain Scale (1-10, being higher the pain the higher the value of the scale)

Secondary outcomes

  1. Lower limb edema

    Time frame: 3 days from intervention

    Evaluation of the circumference of the lower limb undergoing surgery in 3 points: 10 cm above the patella, at the level of the tibial tuberosity and 5 cm below the latter

  2. Lower limb edema

    Time frame: 7 days from intervention

    Evaluation of the circumference of the lower limb undergoing surgery in 3 points: 10 cm above the patella, at the level of the tibial tuberosity and 5 cm below the latter

  3. Lower limb edema

    Time frame: 30 days from intervention

    Evaluation of the circumference of the lower limb undergoing surgery in 3 points: 10 cm above the patella, at the level of the tibial tuberosity and 5 cm below the latter

  4. Analgesic Drugs Use

    Time frame: 3 days from intervention

    Evaluation of the possible use of analgesic drugs for postoperative pain.

  5. Analgesic Drugs Use

    Time frame: 7 days from intervention

    Evaluation of the possible use of analgesic drugs for postoperative pain.

  6. Analgesic Drugs Use

    Time frame: 30 days from intervention

    Evaluation of the possible use of analgesic drugs for postoperative pain.

  7. Discomfort

    Time frame: 3 days from intervention

    Evaluation of the discomfort caused to the patient by the use of stockings using the Aberdeen Varicose Veins Questionnaire .

  8. Discomfort

    Time frame: 7 days from intervention

    Evaluation of the discomfort caused to the patient by the use of stockings using the Aberdeen Varicose Veins Questionnaire .

  9. Discomfort

    Time frame: 30 days from intervention

    Evaluation of the discomfort caused to the patient by the use of stockings using the Aberdeen Varicose Veins Questionnaire .

  10. Postoperative Complications

    Time frame: 3 days from intervention

    Evaluation of the incidence of postoperative complications

  11. Postoperative Complications

    Time frame: 7 days from intervention

    Evaluation of the incidence of postoperative complications

  12. Postoperative Complications

    Time frame: 30 days from intervention

    Evaluation of the incidence of postoperative complications

  13. Evaluation of Quality of Life

    Time frame: 3 days from intervention

    Evaluation of the quality of life using a questionnaire

  14. Evaluation of Quality of Life

    Time frame: 7 from intervention

    Evaluation of the quality of life using a questionnaire

  15. Evaluation of Quality of Life

    Time frame: 30 days from intervention

    Evaluation of the quality of life using a questionnaire.

Sponsors and collaborators

Lead sponsor

IRCCS Policlinico S. Donato

Other

Registry information

Official study title

ElaStic-compressive Stockings at 21 mmHg and 32 mmHg Following Thermal Ablation of the Great Saphenous Vein.

Acronym: CALESSE

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Mar 13, 2023
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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