Adrenaline Reduces Ecchymoses and Hematomas and Improves Quality of Life After Classic Saphenous Vein Stripping (ARESQOLSAVES)

Junior Doctors Network-Hellas

Status: Completed

Conditions: Bruising; Ecchymosis; Venous Insufficiency of Leg; Venous Stasis; Venous Reflux; Venous Disease; Subcutaneous Haematoma; Venous Insufficiency (Chronic)(Peripheral)

Treatments: Drug: Epinephrine Topical; Procedure: Great saphenous vein stripping and varicectomies; Drug: normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04758728

ARES-QOL-SAVES

Details and patient eligibility

About

Aim of the present study is to investigate the efficiency of adrenaline (epinephrine) used locally in reducing and avoiding post-operative formation of subcutaneous ecchymoses and hematomas, in comparison with traditional practice of hemostasis, and to assess improvement in the quality of life of subjects undergoing classic great saphenous vein stripping, who received or did not receive adrenaline as a local hemostatic.

Full description

Introduction Quality of life of subjects undergoing classic great saphenous vein stripping is analogous of the gravity of subcutaneous ecchymoses and hematomas formation, as a result of surgical interventions during open surgery, when the great saphenous vein is being removed. Adrenaline (epinephrine) is a potent vasoconstrictor, whose local hemostatic ability has already been documented and applied in many medical specialties. Aim of the present study to investigate the efficiency of adrenaline (epinephrine) used locally in reducing and avoiding post-operative formation of subcutaneous ecchymoses and hematomas, in comparison with traditional practice of hemostasis, and to assess improvement in the quality of life of subjects undergoing classic great saphenous vein stripping, who received or did not receive adrenaline as a local hemostatic.

Material-Methods 40 subjects diagnosed with chronic venous insufficiency (CVI) and/or varicose veins of the lower limbs of varied clinical gravity (CEAP classification II & III), admitted in the department of Vascular Surgery for open surgical management, i.e. great saphenous vein stripping +/- removal of varicosities, will be enrolled after signing an informed consent for their participation in the study. They will be then randomized into 3 separate groups: Group A - great saphenous vein stripping with local adrenaline use for hemostasis Group B - great saphenous vein stripping with local normal saline use for hemostasis Group C - great saphenous vein stripping with traditional hemostatic practice Study subjects will be followed-up after surgery, and in each group measurement of ecchymoses (small 2-5mm2 and large >5mm2) and hematomas (medium 0,2-1cm and large >1cm) will be performed by using ImageJ software after digital high-resolution photographing on 1st, 8th and 14th post-operative days. Quality of life of subjects will be assessed pre-operatively and 1 month post-operatively, by using SF-36 and CIVIQ-2 questionnaires for QoL in CVI.

Enrollment: 40 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-80 years
• CVI CEAP Class II or III
• Informed consent signed

Exclusion criteria

• Age <18 or >80 years
• CVI CEAP Class I or IV (venous ulcers)
• Allergy to adrenaline history
• No informed consent signed

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

40 participants in 3 patient groups

Group A

Active Comparator group

Description:

Group A - great saphenous vein stripping with local adrenaline use for hemostasis

Treatment:

Procedure: Great saphenous vein stripping and varicectomies

Drug: Epinephrine Topical

Group B

Sham Comparator group

Description:

Group B - great saphenous vein stripping with local normal saline use for hemostasis

Treatment:

Drug: normal saline

Procedure: Great saphenous vein stripping and varicectomies

Group C

Sham Comparator group

Description:

Group C - great saphenous vein stripping with traditional hemostatic practice

Treatment:

Procedure: Great saphenous vein stripping and varicectomies