Adrenaline Reduces Ecchymoses and Hematomas and Improves Quality of Life After Classic Saphenous Vein Stripping
Condition: Venous Insufficiency (Chronic)(Peripheral); Venous Reflux; Venous Insufficiency of Leg; Venous Stasis; Venous Disease; Subcutaneous Haematoma; Ecchymosis; Bruising
MeSH terms: Venous Insufficiency; Varicose Ulcer; Ecchymosis; Hematoma
Study type: Interventional

Summary: 
      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.
    

Detailed 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.
    

Intervention name(s): Great saphenous vein stripping and varicectomies; Epinephrine Topical; normal saline
Intervention type(s): Procedure; Drug; Drug
Intervention description(s): Removal of the great saphenous vein (partially - from just below the knee up to the saphenofemoral junction) by two 3cm skin and subcutaneous fat incisions and the introduction of a conventional vein stripper device, under general or epidural/regional anesthesia. Removal of varicose veins of the lower limb by 0,5cm skin incisions and the use of a conventional phlebectomy stainless steel hook. Mechanical hemostasis by direct compression of the thigh for 10 minutes.; Use of epinephrine/adrenaline solution 1:1000 topically; Use of normal saline solution NaCl 0,9% topically
Other intervention name(s): Saphenectomy; Adrenaline solution 1:1000 topical/local use; NaCl 0,9% topical/local use
Intervention MeSH terms: Epinephrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: great saphenous vein; saphenectomy; saphenous vein stripping; ecchymosis; haematoma; adrenaline; epinephrin; hemostasis; chronic venous insufficiency; venous reflux; venous disease