Adrenaline Reduces Ecchymoses and Hematomas and Improves Quality of Life After Classic Saphenous Vein Stripping
ARESQOLSAVES
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
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 14, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 10, 2016
CompletedFirst Submitted
Initial submission to the registry
February 9, 2021
CompletedFirst Posted
Study publicly available on registry
February 17, 2021
CompletedFebruary 18, 2021
February 1, 2021
8 months
February 9, 2021
February 17, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (16)
Subcutaneous ecchymoses number 1d-postop
The absolute number of subcutaneous ecchymoses on the operated limb on 1st post-operative day
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
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
336 hours post-operatively
Subcutaneous hematomas number 1d-postop
The absolute number of subcutaneous hematomas in the operated limb on 1st post-operative day
24 hours post-operatively
Subcutaneous hematomas number 8d-postop
The absolute number of subcutaneous hematomas in the operated limb on 8th post-operative day
192 hours post-operatively
Subcutaneous hematomas number 14d-postop
The absolute number of subcutaneous hematomas in the operated limb on 14th post-operative day
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
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
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
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
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
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
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.
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.
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.
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.
30 days post-operatively
Secondary Outcomes (18)
HCT preop
24 hours pre-operatively
HCT postop
24 hours post-operatively
Hgb preop
24 hours pre-operatively
Hgb postop
24 hours post-operatively
WBC preop
24 hours pre-operatively
- +13 more secondary outcomes
Study Arms (3)
Group A
ACTIVE COMPARATORGroup A - great saphenous vein stripping with local adrenaline use for hemostasis
Group B
SHAM COMPARATORGroup B - great saphenous vein stripping with local normal saline use for hemostasis
Group C
SHAM COMPARATORGroup C - great saphenous vein stripping with traditional hemostatic practice
Interventions
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.
Use of epinephrine/adrenaline solution 1:1000 topically
Use of normal saline solution NaCl 0,9% topically
Eligibility Criteria
You may qualify if:
- Age 18-80 years
- CVI CEAP Class II or III
- Informed consent signed
You may not qualify if:
- Age \<18 or \>80 years
- CVI CEAP Class I or IV (venous ulcers)
- Allergy to adrenaline history
- No informed consent signed
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Junior Doctors Network-Hellaslead
- General Hospital of Rhodes Andreas Papandreoucollaborator
- Hellenic Red Cross Hospitalcollaborator
Study Sites (1)
Department of Vascular Surgery, Andreas Papandreou General Hospital
Rhodes, South Aegean, 85133, Greece
Related Publications (5)
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.
PMID: 1522653BACKGROUNDNisar 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.
PMID: 16236532BACKGROUNDPappa 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.
PMID: 16047519BACKGROUNDAndreozzi 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.
PMID: 16158038BACKGROUNDKim 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.
PMID: 32028367BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Konstantinos Roditis, MD, MSc
JDN-Hellas / Department of Vascular Surgery, Hellenic Red Cross Hospital
- STUDY CHAIR
Dimitrios Mavros, MD, MSc, PhD
Department of Vascular Surgery, Andreas Papandreou General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, MSc, Chief Resident, JDN-Hellas Board Chairperson
Study Record Dates
First Submitted
February 9, 2021
First Posted
February 17, 2021
Study Start
September 10, 2015
Primary Completion
May 14, 2016
Study Completion
June 10, 2016
Last Updated
February 18, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share