Bruising, Ecchymosis, Subcutaneous Haematoma, Venous Disease, Venous Insufficiency (Chronic)(Peripheral), Venous Insufficiency of Leg, Venous Reflux, Venous Stasis
Conditions
Keywords
great saphenous vein, saphenectomy, saphenous vein stripping, ecchymosis, haematoma, adrenaline, epinephrin, hemostasis, chronic venous insufficiency, venous reflux, venous disease
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.
Interventions
PROCEDUREGreat saphenous vein stripping and varicectomies
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.
DRUGEpinephrine Topical
Use of epinephrine/adrenaline solution 1:1000 topically
DRUGnormal saline
Use of normal saline solution NaCl 0,9% topically
Sponsors
General Hospital of Rhodes Andreas Papandreou
Hellenic Red Cross Hospital
Junior Doctors Network-Hellas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 14d-postop | 336 hours post-operatively | The absolute number of subcutaneous hematomas in 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 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 1d-postop | 24 hours post-operatively | The total area in mm2 of subcutaneous hematomas in the operated limb on 1st 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 |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| CRP preop | 24 hours pre-operatively | Serum C-reactive protein (CRP) measured pre-operatively, in mg/L. |
| 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. |
| CRP postop | 24 hours post-operatively | Serum C-reactive protein (CRP) measured post-operatively, in mg/L. |
| 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). |
| 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. |
Countries
Greece
Outcome results
None listed