Venous Reflux Clinical Trial
— ARESQOLSAVESOfficial title:
The Role of Adrenaline in the Reduction of Subcutaneous Ecchymoses and Hematomas and in the Improvement of the Quality of Life of Patients After Classic Great Saphenous Vein Stripping
Verified date | February 2021 |
Source | Junior Doctors Network-Hellas |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | June 10, 2016 |
Est. primary completion date | May 14, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Greece | Department of Vascular Surgery, Andreas Papandreou General Hospital | Rhodes | South Aegean |
Lead Sponsor | Collaborator |
---|---|
Junior Doctors Network-Hellas | Andreas Papandreou Rhodes General Hospital, Hellenic Red Cross Hospital |
Greece,
Andreozzi GM, Cordova RM, Scomparin A, Martini R, D'Eri A, Andreozzi F; Quality of Life Working Group on Vascular Medicine of SIAPAV. Quality of life in chronic venous insufficiency. An Italian pilot study of the Triveneto Region. Int Angiol. 2005 Sep;24(3):272-7. — View Citation
Furuya T, Tada Y, Sato O. A new technique for reducing subcutaneous hemorrhage after stripping of the great saphenous vein. J Vasc Surg. 1992 Sep;16(3):493-4. — View Citation
Kim H, Hwang K, Yun SM, Kim DJ. Usage of Epinephrine Mixed With Lidocaine in Plastic Surgery. J Craniofac Surg. 2020 May/Jun;31(3):791-793. doi: 10.1097/SCS.0000000000006156. — View Citation
Nisar A, Shabbir J, Tubassam MA, Shah AR, Khawaja N, Kavanagh EG, Grace PA, Burke PE. Local anaesthetic flush reduces postoperative pain and haematoma formation after great saphenous vein stripping--a randomised controlled trial. Eur J Vasc Endovasc Surg. 2006 Mar;31(3):325-31. Epub 2005 Oct 19. — View Citation
Pappa E, Kontodimopoulos N, Niakas D. Validating and norming of the Greek SF-36 Health Survey. Qual Life Res. 2005 Jun;14(5):1433-8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Subcutaneous ecchymoses number 1d-postop | The absolute number of subcutaneous ecchymoses on the operated limb on 1st post-operative day | 24 hours post-operatively | |
Primary | Subcutaneous ecchymoses number 8d-post-op | The absolute number of subcutaneous ecchymoses on the operated limb on 8th post-operative day | 192 hours post-operatively | |
Primary | Subcutaneous ecchymoses number 14d-post-op | The absolute number of subcutaneous ecchymoses on the operated limb on 14th post-operative day | 336 hours post-operatively | |
Primary | Subcutaneous hematomas number 1d-postop | The absolute number of subcutaneous hematomas in the operated limb on 1st post-operative day | 24 hours post-operatively | |
Primary | Subcutaneous hematomas number 8d-postop | The absolute number of subcutaneous hematomas in the operated limb on 8th post-operative day | 192 hours post-operatively | |
Primary | Subcutaneous hematomas number 14d-postop | The absolute number of subcutaneous hematomas in the operated limb on 14th post-operative day | 336 hours post-operatively | |
Primary | Subcutaneous ecchymoses total area 1d-postop | The total area in mm2 of subcutaneous ecchymoses in the operated limb on 1st post-operative day | 24 hours post-operatively | |
Primary | Subcutaneous ecchymoses total area 8d-postop | The total area in mm2 of subcutaneous ecchymoses in the operated limb on 8th post-operative day | 192 hours post-operatively | |
Primary | Subcutaneous ecchymoses total area 14d-postop | The total area in mm2 of subcutaneous ecchymoses in the operated limb on 14th post-operative day | 336 hours post-operatively | |
Primary | Subcutaneous hematomas total area 1d-postop | The total area in mm2 of subcutaneous hematomas in the operated limb on 1st post-operative day | 24 hours post-operatively | |
Primary | Subcutaneous hematomas total area 8d-postop | The total area in mm2 of subcutaneous hematomas in the operated limb on 8th post-operative day | 192 hours post-operatively | |
Primary | Subcutaneous hematomas total area 14d-postop | The total area in mm2 of subcutaneous hematomas in the operated limb on 14th post-operative day | 336 hours post-operatively | |
Primary | 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. | 24 hours pre-operatively | |
Primary | 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. | 30 days post-operatively | |
Primary | 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. | 24 hours pre-operatively | |
Primary | 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. | 30 days post-operatively | |
Secondary | HCT preop | Hematocrit (HCT) measured pre-operatively, in percentage (%). | 24 hours pre-operatively | |
Secondary | HCT postop | Hematocrit (HCT) measured post-operatively, in percentage (%). | 24 hours post-operatively | |
Secondary | Hgb preop | Hemoglobin (Hgb) measured pre-operatively, in mg/dL. | 24 hours pre-operatively | |
Secondary | Hgb postop | Hemoglobin (Hgb) measured post-operatively, in mg/dL. | 24 hours post-operatively | |
Secondary | WBC preop | White blood cells (WBC) count measured pre-operatively, in K/mcL. | 24 hours pre-operatively | |
Secondary | WBC postop | White blood cells (WBC) count measured post-operatively, in K/mcL. | 24 hours post-operatively | |
Secondary | PLT preop | Platelet count (PLT) measured pre-operatively, in K/mcL. | 24 hours pre-operatively | |
Secondary | PLT postop | Platelet count (PLT) measured post-operatively, in K/mcL. | 24 hours post-operatively | |
Secondary | FIB preop | Fibrinogen (FIB) measured pre-operatively, in mg/dL. | 24 hours pre-operatively | |
Secondary | FIB postop | Fibrinogen (FIB) measured post-operatively, in mg/dL. | 24 hours post-operatively | |
Secondary | ESR preop | Erythrocyte sedimentation rate on the 1st hour, measured pre-operatively, in millimeters (mm). | 24 hours pre-operatively | |
Secondary | ESR postop | Erythrocyte sedimentation rate on the 1st hour, measured post-operatively, in millimeters (mm). | 24 hours post-operatively | |
Secondary | CRP preop | Serum C-reactive protein (CRP) measured pre-operatively, in mg/L. | 24 hours pre-operatively | |
Secondary | CRP postop | Serum C-reactive protein (CRP) measured post-operatively, in mg/L. | 24 hours post-operatively | |
Secondary | 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. | 24 hours pre-operatively | |
Secondary | 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. | 24 hours post-operatively | |
Secondary | 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. | 192 hours post-operatively | |
Secondary | 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. | 336 hours post-operatively |
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