Adrenaline Reduces Ecchymoses and Hematomas and Improves Quality of Life After Classic Saphenous Vein Stripping
- Conditions
- Venous StasisEcchymosisVenous RefluxVenous DiseaseSubcutaneous HaematomaVenous Insufficiency (Chronic)(Peripheral)Venous Insufficiency of LegBruising
- Interventions
- Procedure: Great saphenous vein stripping and varicectomiesDrug: normal saline
- Registration Number
- NCT04758728
- Lead Sponsor
- Junior Doctors Network-Hellas
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- Age 18-80 years
- CVI CEAP Class II or III
- Informed consent signed
- Age <18 or >80 years
- CVI CEAP Class I or IV (venous ulcers)
- Allergy to adrenaline history
- No informed consent signed
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A Great saphenous vein stripping and varicectomies Group A - great saphenous vein stripping with local adrenaline use for hemostasis Group B Great saphenous vein stripping and varicectomies Group B - great saphenous vein stripping with local normal saline use for hemostasis Group B normal saline Group B - great saphenous vein stripping with local normal saline use for hemostasis Group C Great saphenous vein stripping and varicectomies Group C - great saphenous vein stripping with traditional hemostatic practice Group A Epinephrine Topical Group A - great saphenous vein stripping with local adrenaline use for hemostasis
- Primary Outcome Measures
Name Time Method Subcutaneous ecchymoses number 1d-postop 24 hours post-operatively The absolute number of subcutaneous ecchymoses on the operated limb on 1st post-operative day
Subcutaneous ecchymoses number 8d-post-op 192 hours post-operatively The absolute number of subcutaneous ecchymoses on the operated limb on 8th post-operative day
Subcutaneous ecchymoses number 14d-post-op 336 hours post-operatively The absolute number of subcutaneous ecchymoses on the operated limb on 14th post-operative day
Subcutaneous hematomas number 1d-postop 24 hours post-operatively The absolute number of subcutaneous hematomas in the operated limb on 1st post-operative day
Subcutaneous hematomas number 8d-postop 192 hours post-operatively The absolute number of subcutaneous hematomas in the operated limb on 8th post-operative day
Subcutaneous hematomas number 14d-postop 336 hours post-operatively The absolute number of subcutaneous hematomas in the operated limb on 14th post-operative day
Subcutaneous ecchymoses total area 1d-postop 24 hours post-operatively The total area in mm2 of subcutaneous ecchymoses in the operated limb on 1st post-operative day
Subcutaneous ecchymoses total area 8d-postop 192 hours post-operatively The total area in mm2 of subcutaneous ecchymoses in the operated limb on 8th post-operative day
Subcutaneous ecchymoses total area 14d-postop 336 hours post-operatively The total area in mm2 of subcutaneous ecchymoses in the operated limb on 14th post-operative day
Subcutaneous hematomas total area 8d-postop 192 hours post-operatively The total area in mm2 of subcutaneous hematomas in the operated limb on 8th post-operative day
Subcutaneous hematomas total area 14d-postop 336 hours post-operatively The total area in mm2 of subcutaneous hematomas in the operated limb on 14th post-operative day
Subcutaneous hematomas total area 1d-postop 24 hours post-operatively The total area in mm2 of subcutaneous hematomas in the operated limb on 1st post-operative day
QoL-CIVIQ2 1month post-op 30 days post-operatively Quality of life assessment based on the CIVIQ-2 questionnaire 1 month post-operatively. Quality of life assessment based on the ChronIc Venous Insufficiency quality of life Questionnaire version 2 (CIVIQ-2) questionnaire preoperatively. The CIVIQ was developed and validated (relevance, acceptability, reliability, construct validity, and sensitivity) by French researchers in 1996. The CIVIQ is a 20-item self-reported instrument that includes four categories of questions: physical (4 items), psychological (9 items), social (4 items), and pain (3 items). Its score ranges from 0, the worst score, to 100, the best. There are five possible answers (from 1 to 5) to describe each symptom and the sensation of discomfort. The second version, the CIVIQ-2 (where 2 denotes the second draft of the same questionnaire), provides a global score covering all aspects of the questionnaire and weighs the categories equally.
QoL-SF36 preop 24 hours pre-operatively Quality of life assessment based on the 36-Item Short Form Survey (SF-36) questionnaire preoperatively. It is an often-used, well-researched, self-reported measure of health. It stems from a study called the Medical Outcomes Study. It taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. The eight scaled scores, which are the weighted sums of the questions in their section are directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
QoL-SF36 1month-postop 30 days post-operatively Quality of life assessment based on the 36-Item Short Form Survey (SF-36) questionnaire 30 days post-operatively. It is an often-used, well-researched, self-reported measure of health. It stems from a study called the Medical Outcomes Study. It taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. The eight scaled scores, which are the weighted sums of the questions in their section are directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
QoL-CIVIQ2 preop 24 hours pre-operatively Quality of life assessment based on the ChronIc Venous Insufficiency quality of life Questionnaire version 2 (CIVIQ-2) questionnaire preoperatively. The CIVIQ was developed and validated (relevance, acceptability, reliability, construct validity, and sensitivity) by French researchers in 1996. The CIVIQ is a 20-item self-reported instrument that includes four categories of questions: physical (4 items), psychological (9 items), social (4 items), and pain (3 items). Its score ranges from 0, the worst score, to 100, the best. There are five possible answers (from 1 to 5) to describe each symptom and the sensation of discomfort. The second version, the CIVIQ-2 (where 2 denotes the second draft of the same questionnaire), provides a global score covering all aspects of the questionnaire and weighs the categories equally.
- Secondary Outcome Measures
Name Time Method HCT preop 24 hours pre-operatively Hematocrit (HCT) measured pre-operatively, in percentage (%).
HCT postop 24 hours post-operatively Hematocrit (HCT) measured post-operatively, in percentage (%).
Hgb preop 24 hours pre-operatively Hemoglobin (Hgb) measured pre-operatively, in mg/dL.
Hgb postop 24 hours post-operatively Hemoglobin (Hgb) measured post-operatively, in mg/dL.
WBC preop 24 hours pre-operatively White blood cells (WBC) count measured pre-operatively, in K/mcL.
WBC postop 24 hours post-operatively White blood cells (WBC) count measured post-operatively, in K/mcL.
PLT preop 24 hours pre-operatively Platelet count (PLT) measured pre-operatively, in K/mcL.
PLT postop 24 hours post-operatively Platelet count (PLT) measured post-operatively, in K/mcL.
FIB preop 24 hours pre-operatively Fibrinogen (FIB) measured pre-operatively, in mg/dL.
FIB postop 24 hours post-operatively Fibrinogen (FIB) measured post-operatively, in mg/dL.
ESR preop 24 hours pre-operatively Erythrocyte sedimentation rate on the 1st hour, measured pre-operatively, in millimeters (mm).
ESR postop 24 hours post-operatively Erythrocyte sedimentation rate on the 1st hour, measured post-operatively, in millimeters (mm).
CRP preop 24 hours pre-operatively Serum C-reactive protein (CRP) measured pre-operatively, in mg/L.
CRP postop 24 hours post-operatively Serum C-reactive protein (CRP) measured post-operatively, in mg/L.
Experienced pain preop 24 hours pre-operatively Pain experienced pre-operatively assessed by a numeric rating pain scale (0-10). Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is for adults and children 10 years old or older. 0 indicates no pain, 5 moderate and 10 worst possible pain.
Experienced pain 1d-postop 24 hours post-operatively Pain experienced pre-operatively assessed by a numeric rating pain scale (0-10). Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is for adults and children 10 years old or older. 0 indicates no pain, 5 moderate and 10 worst possible pain.
Experienced pain 8d-postop 192 hours post-operatively Pain experienced pre-operatively assessed by a numeric rating pain scale (0-10). Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is for adults and children 10 years old or older. 0 indicates no pain, 5 moderate and 10 worst possible pain.
Experienced pain 14d-postop 336 hours post-operatively Pain experienced pre-operatively assessed by a numeric rating pain scale (0-10). Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is for adults and children 10 years old or older. 0 indicates no pain, 5 moderate and 10 worst possible pain.
Trial Locations
- Locations (1)
Department of Vascular Surgery, Andreas Papandreou General Hospital
🇬🇷Rhodes, South Aegean, Greece