An interventional study of Great saphenous vein stripping and varicectomies and Epinephrine Topical in Venous Insufficiency (Chronic)(Peripheral), Venous Reflux and Venous Insufficiency of Leg, sponsored by Junior Doctors Network-Hellas. Completed at 1 site in Greece. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-02-18.
Sponsored by Junior Doctors Network-Hellas · Not applicable, Interventional, and Prevention
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.
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.
162 studies on the registry are indexed under Venous Insufficiency; 14 are open to participants now.
This study's enrollment of 40 is below the median of 60 across 127 interventional studies indexed under Venous Insufficiency.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group A - great saphenous vein stripping with local adrenaline use for hemostasis
Procedure: Great saphenous vein stripping and varicectomies · Drug: Epinephrine Topical
Group B - great saphenous vein stripping with local normal saline use for hemostasis
Procedure: Great saphenous vein stripping and varicectomies · Drug: normal saline
Group C - great saphenous vein stripping with traditional hemostatic practice
Procedure: Great 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.
Also known as: Saphenectomy
Use of epinephrine/adrenaline solution 1:1000 topically
Also known as: Adrenaline solution 1:1000 topical/local use
Use of normal saline solution NaCl 0,9% topically
Also known as: NaCl 0,9% topical/local use
Subcutaneous ecchymoses number 1d-postop
The absolute number of subcutaneous ecchymoses on the operated limb on 1st post-operative day
Time frame: 24 hours post-operatively
Subcutaneous ecchymoses number 8d-post-op
The absolute number of subcutaneous ecchymoses on the operated limb on 8th post-operative day
Time frame: 192 hours post-operatively
Subcutaneous ecchymoses number 14d-post-op
The absolute number of subcutaneous ecchymoses on the operated limb on 14th post-operative day
Time frame: 336 hours post-operatively
Subcutaneous hematomas number 1d-postop
The absolute number of subcutaneous hematomas in the operated limb on 1st post-operative day
Time frame: 24 hours post-operatively
Subcutaneous hematomas number 8d-postop
The absolute number of subcutaneous hematomas in the operated limb on 8th post-operative day
Time frame: 192 hours post-operatively
Subcutaneous hematomas number 14d-postop
The absolute number of subcutaneous hematomas in the operated limb on 14th post-operative day
Time frame: 336 hours post-operatively
Subcutaneous ecchymoses total area 1d-postop
The total area in mm2 of subcutaneous ecchymoses in the operated limb on 1st post-operative day
Time frame: 24 hours post-operatively
Subcutaneous ecchymoses total area 8d-postop
The total area in mm2 of subcutaneous ecchymoses in the operated limb on 8th post-operative day
Time frame: 192 hours post-operatively
Subcutaneous ecchymoses total area 14d-postop
The total area in mm2 of subcutaneous ecchymoses in the operated limb on 14th post-operative day
Time frame: 336 hours post-operatively
Subcutaneous hematomas total area 1d-postop
The total area in mm2 of subcutaneous hematomas in the operated limb on 1st post-operative day
Time frame: 24 hours post-operatively
Subcutaneous hematomas total area 8d-postop
The total area in mm2 of subcutaneous hematomas in the operated limb on 8th post-operative day
Time frame: 192 hours post-operatively
Subcutaneous hematomas total area 14d-postop
The total area in mm2 of subcutaneous hematomas in the operated limb on 14th post-operative day
Time frame: 336 hours post-operatively
QoL-SF36 preop
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.
Time frame: 24 hours pre-operatively
QoL-SF36 1month-postop
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.
Time frame: 30 days post-operatively
QoL-CIVIQ2 preop
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.
Time frame: 24 hours pre-operatively
QoL-CIVIQ2 1month post-op
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.
Time frame: 30 days post-operatively
HCT preop
Hematocrit (HCT) measured pre-operatively, in percentage (%).
Time frame: 24 hours pre-operatively
HCT postop
Hematocrit (HCT) measured post-operatively, in percentage (%).
Time frame: 24 hours post-operatively
Hgb preop
Hemoglobin (Hgb) measured pre-operatively, in mg/dL.
Time frame: 24 hours pre-operatively
Hgb postop
Hemoglobin (Hgb) measured post-operatively, in mg/dL.
Time frame: 24 hours post-operatively
WBC preop
White blood cells (WBC) count measured pre-operatively, in K/mcL.
Time frame: 24 hours pre-operatively
WBC postop
White blood cells (WBC) count measured post-operatively, in K/mcL.
Time frame: 24 hours post-operatively
PLT preop
Platelet count (PLT) measured pre-operatively, in K/mcL.
Time frame: 24 hours pre-operatively
PLT postop
Platelet count (PLT) measured post-operatively, in K/mcL.
Time frame: 24 hours post-operatively
FIB preop
Fibrinogen (FIB) measured pre-operatively, in mg/dL.
Time frame: 24 hours pre-operatively
FIB postop
Fibrinogen (FIB) measured post-operatively, in mg/dL.
Time frame: 24 hours post-operatively
ESR preop
Erythrocyte sedimentation rate on the 1st hour, measured pre-operatively, in millimeters (mm).
Time frame: 24 hours pre-operatively
ESR postop
Erythrocyte sedimentation rate on the 1st hour, measured post-operatively, in millimeters (mm).
Time frame: 24 hours post-operatively
CRP preop
Serum C-reactive protein (CRP) measured pre-operatively, in mg/L.
Time frame: 24 hours pre-operatively
CRP postop
Serum C-reactive protein (CRP) measured post-operatively, in mg/L.
Time frame: 24 hours post-operatively
Experienced pain preop
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.
Time frame: 24 hours pre-operatively
Experienced pain 1d-postop
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.
Time frame: 24 hours post-operatively
Experienced pain 8d-postop
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.
Time frame: 192 hours post-operatively
Experienced pain 14d-postop
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.
Time frame: 336 hours post-operatively
Plan to share: No
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