Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04758728
Status:
COMPLETED
Last Update Posted:
2021-02-18
First Post:
2021-02-09
Brief Title:
Adrenaline Reduces Ecchymoses and Hematomas and Improves Quality of Life After Classic Saphenous Vein Stripping
Sponsor:
Junior Doctors Network-Hellas
Organization:
Junior Doctors Network-Hellas
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARESQOLSAVES
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 andor 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 ie 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 02-1cm 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
Material-Methods 40 subjects diagnosed with chronic venous insufficiency CVI andor 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 ie 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 02-1cm 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None