Venous Insufficiency (Chronic)(Peripheral)ARESQOLSAVESNCT04758728
Adrenaline Reduces Ecchymoses and Hematomas and Improves Quality of Life After Classic Saphenous Vein Stripping
A study testing Great saphenous vein stripping and varicectomies, Epinephrine Topical and normal saline in people with Venous Insufficiency (Chronic)(Peripheral) and Venous Reflux, run by Junior Doctors Network-Hellas at 1 site in Greece.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Venous Insufficiency (Chronic)(Peripheral), Venous Reflux, Venous Insufficiency of Leg
- What is being tested?
- Great saphenous vein stripping and varicectomies, Epinephrine Topical and normal saline
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGreece
- Study dates
- 10 Sep 2015to 10 Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years
- CVI CEAP Class II or III
- Informed consent signed
Who cannot join
- Age <18 or >80 years
- CVI CEAP Class I or IV (venous ulcers)
- Allergy to adrenaline history
- No informed consent signed
Trial locations and contacts
1 site in 1 country.
Greece1 site
Department of Vascular Surgery, Andreas Papandreou General Hospital
Rhodes, South Aegean, 85133
About this study
Official 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
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.
Read the 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.
- Conditions
- Venous Insufficiency (Chronic)(Peripheral), Venous Reflux, Venous Insufficiency of Leg, Venous Stasis, Venous Disease, Subcutaneous Haematoma
- Being tested
- Great saphenous vein stripping and varicectomies, Epinephrine Topical, normal saline
- Keywords
- great saphenous vein, saphenectomy, saphenous vein stripping, ecchymosis, haematoma, adrenaline, epinephrin, hemostasis, chronic venous insufficiency, venous reflux, venous disease
- Medical subject headings
- Venous Insufficiency, Varicose Ulcer, Ecchymosis, Contusions, Hematoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Great saphenous vein stripping and varicectomiesProcedure or surgery
Also called Saphenectomy
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.
Epinephrine TopicalDrug
Also called Adrenaline solution 1:1000 topical/local use
Use of epinephrine/adrenaline solution 1:1000 topically
normal salineDrug
Also called NaCl 0,9% topical/local use
Use of normal saline solution NaCl 0,9% topically
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Group A - great saphenous vein stripping with local adrenaline use for hemostasis Receives: Procedure: Great saphenous vein stripping and varicectomies; Drug: Epinephrine Topical |
| Group B | Sham comparator | Group B - great saphenous vein stripping with local normal saline use for hemostasis Receives: Procedure: Great saphenous vein stripping and varicectomies; Drug: normal saline |
| Group C | Sham comparator | Group C - great saphenous vein stripping with traditional hemostatic practice Receives: Procedure: Great saphenous vein stripping and varicectomies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subcutaneous ecchymoses number 1d-postop
The absolute number of subcutaneous ecchymoses on the operated limb on 1st post-operative day
Measured: 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
Measured: 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
Measured: 336 hours post-operatively
Subcutaneous hematomas number 1d-postop
The absolute number of subcutaneous hematomas in the operated limb on 1st post-operative day
Measured: 24 hours post-operatively
Subcutaneous hematomas number 8d-postop
The absolute number of subcutaneous hematomas in the operated limb on 8th post-operative day
Measured: 192 hours post-operatively
Subcutaneous hematomas number 14d-postop
The absolute number of subcutaneous hematomas in the operated limb on 14th post-operative day
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30 days post-operatively
Secondary outcomes (18)
HCT preop
Hematocrit (HCT) measured pre-operatively, in percentage (%).
Measured: 24 hours pre-operatively
HCT postop
Hematocrit (HCT) measured post-operatively, in percentage (%).
Measured: 24 hours post-operatively
Hgb preop
Hemoglobin (Hgb) measured pre-operatively, in mg/dL.
Measured: 24 hours pre-operatively
Hgb postop
Hemoglobin (Hgb) measured post-operatively, in mg/dL.
Measured: 24 hours post-operatively
WBC preop
White blood cells (WBC) count measured pre-operatively, in K/mcL.
Measured: 24 hours pre-operatively
WBC postop
White blood cells (WBC) count measured post-operatively, in K/mcL.
Measured: 24 hours post-operatively
PLT preop
Platelet count (PLT) measured pre-operatively, in K/mcL.
Measured: 24 hours pre-operatively
PLT postop
Platelet count (PLT) measured post-operatively, in K/mcL.
Measured: 24 hours post-operatively
FIB preop
Fibrinogen (FIB) measured pre-operatively, in mg/dL.
Measured: 24 hours pre-operatively
FIB postop
Fibrinogen (FIB) measured post-operatively, in mg/dL.
Measured: 24 hours post-operatively
ESR preop
Erythrocyte sedimentation rate on the 1st hour, measured pre-operatively, in millimeters (mm).
Measured: 24 hours pre-operatively
ESR postop
Erythrocyte sedimentation rate on the 1st hour, measured post-operatively, in millimeters (mm).
Measured: 24 hours post-operatively
CRP preop
Serum C-reactive protein (CRP) measured pre-operatively, in mg/L.
Measured: 24 hours pre-operatively
CRP postop
Serum C-reactive protein (CRP) measured post-operatively, in mg/L.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 336 hours post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start10 Sep 2015
- Primary completion14 May 2016
- Study completion10 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Venous Insufficiency (Chronic)(Peripheral)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Junior Doctors Network-Hellas
- Sponsor type
- University, hospital or other
- Collaborators
- General Hospital of Rhodes Andreas Papandreou, Hellenic Red Cross Hospital
- Responsible party
- Principal investigator, Konstantinos Roditis, Junior Doctors Network-Hellas
- Investigators
- Konstantinos Roditis, MD, MSc, Principal investigator, JDN-Hellas / Department of Vascular Surgery, Hellenic Red Cross HospitalDimitrios Mavros, MD, MSc, PhD, Study chair, Department of Vascular Surgery, Andreas Papandreou General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04758728
- Sponsor's protocol ID
- ARES-QOL-SAVES
- Acronym
- ARESQOLSAVES
- Status last verified
- Feb 2021
- First submitted
- 9 Feb 2021
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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. doi: 10.1016/0741-5214(92)90389-p. No abstract available.
PubMed 1522653Nisar 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. doi: 10.1016/j.ejvs.2005.08.006. Epub 2005 Oct 19.
PubMed 16236532Pappa E, Kontodimopoulos N, Niakas D. Validating and norming of the Greek SF-36 Health Survey. Qual Life Res. 2005 Jun;14(5):1433-8. doi: 10.1007/s11136-004-6014-y.
PubMed 16047519Andreozzi 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.
PubMed 16158038Kim 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.
PubMed 32028367
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04758728
- Acronym / sponsor ID
- ARESQOLSAVES / ARES-QOL-SAVES
- Conditions
- Venous Insufficiency (Chronic)(Peripheral), Venous Reflux, Venous Insufficiency of Leg, Venous Stasis, Venous Disease, Subcutaneous Haematoma
- Keywords
- great saphenous vein, saphenectomy, saphenous vein stripping, ecchymosis, haematoma, adrenaline, epinephrin, hemostasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Junior Doctors Network-HellasUniversity, hospital or other
- Collaborators
- General Hospital of Rhodes Andreas Papandreou, Hellenic Red Cross Hospital
- Study start
- 10 Sep 2015 (actual)
- Primary completion
- 14 May 2016 (actual)
- Study completion
- 10 Jun 2016 (actual)
- First posted
- 17 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: Great saphenous vein stripping and varicectomies, Drug: Epinephrine TopicalGroup A - great saphenous vein stripping with local adrenaline use for hemostasis |
| Group B | Sham comparator | Procedure: Great saphenous vein stripping and varicectomies, Drug: normal salineGroup B - great saphenous vein stripping with local normal saline use for hemostasis |
| Group C | Sham comparator | Procedure: Great saphenous vein stripping and varicectomiesGroup C - great saphenous vein stripping with traditional hemostatic practice |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-80 years
- CVI CEAP Class II or III
- Informed consent signed
Key exclusion criteria (4 listed)
- Age <18 or >80 years
- CVI CEAP Class I or IV (venous ulcers)
- Allergy to adrenaline history
- No informed consent signed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Great saphenous vein stripping and varicectomiesAlso: SaphenectomyRemoval 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. | Procedure or surgery | Group A, Group B, Group C |
| Epinephrine TopicalAlso: Adrenaline solution 1:1000 topical/local useUse of epinephrine/adrenaline solution 1:1000 topically | Drug | Group A |
| normal salineAlso: NaCl 0,9% topical/local useUse of normal saline solution NaCl 0,9% topically | Drug | Group B |
Primary outcome
Subcutaneous ecchymoses number 1d-postop
Time frame: 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
Time frame: 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
Time frame: 336 hours post-operatively
The absolute number of subcutaneous ecchymoses on the operated limb on 14th post-operative day
Subcutaneous hematomas number 1d-postop
Time frame: 24 hours post-operatively
The absolute number of subcutaneous hematomas in the operated limb on 1st post-operative day
Subcutaneous hematomas number 8d-postop
Time frame: 192 hours post-operatively
The absolute number of subcutaneous hematomas in the operated limb on 8th post-operative day
Subcutaneous hematomas number 14d-postop
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 336 hours post-operatively
The total area in mm2 of subcutaneous hematomas in the operated limb on 14th post-operative day
QoL-SF36 preop
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
18 secondary outcomes
HCT preop
Time frame: 24 hours pre-operatively
HCT postop
Time frame: 24 hours post-operatively
Hgb preop
Time frame: 24 hours pre-operatively
Hgb postop
Time frame: 24 hours post-operatively
WBC preop
Time frame: 24 hours pre-operatively
WBC postop
Time frame: 24 hours post-operatively
PLT preop
Time frame: 24 hours pre-operatively
PLT postop
Time frame: 24 hours post-operatively
FIB preop
Time frame: 24 hours pre-operatively
FIB postop
Time frame: 24 hours post-operatively
ESR preop
Time frame: 24 hours pre-operatively
ESR postop
Time frame: 24 hours post-operatively
CRP preop
Time frame: 24 hours pre-operatively
CRP postop
Time frame: 24 hours post-operatively
Experienced pain preop
Time frame: 24 hours pre-operatively
Experienced pain 1d-postop
Time frame: 24 hours post-operatively
Experienced pain 8d-postop
Time frame: 192 hours post-operatively
Experienced pain 14d-postop
Time frame: 336 hours post-operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Background: PubMed 1522653Furuya 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. doi: 10.1016/0741-5214(92)90389-p. No abstract available.
- Background: PubMed 16236532Nisar 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. doi: 10.1016/j.ejvs.2005.08.006. Epub 2005 Oct 19.
- Background: PubMed 16047519Pappa E, Kontodimopoulos N, Niakas D. Validating and norming of the Greek SF-36 Health Survey. Qual Life Res. 2005 Jun;14(5):1433-8. doi: 10.1007/s11136-004-6014-y.
- Background: PubMed 16158038Andreozzi 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.
- Background: PubMed 32028367Kim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Konstantinos Roditis, MD, MSc principal investigator
JDN-Hellas / Department of Vascular Surgery, Hellenic Red Cross Hospital
Dimitrios Mavros, MD, MSc, PhD study chair
Department of Vascular Surgery, Andreas Papandreou General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Great saphenous vein stripping and varicectomies, Epinephrine Topical and normal saline in people with Venous Insufficiency (Chronic)(Peripheral) and Venous Reflux, run by Junior Doctors Network-Hellas at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subcutaneous ecchymoses number 1d-postop (time frame: 24 hours post-operatively). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04758728, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.