Adrenaline Reduces Ecchymoses and Hematomas and Improves Quality of Life After Classic Saphenous Vein Stripping
NCT04758728 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2021-02-18
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.
Conditions
- Venous Insufficiency (Chronic)(Peripheral)
- Venous Reflux
- Venous Insufficiency of Leg
- Venous Stasis
- Venous Disease
- Subcutaneous Haematoma
- Ecchymosis
- Bruising
Interventions
- 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.
- DRUG
-
Epinephrine Topical
Use of epinephrine/adrenaline solution 1:1000 topically
- DRUG
-
normal saline
Use of normal saline solution NaCl 0,9% topically
Sponsors & Collaborators
-
General Hospital of Rhodes Andreas Papandreou
collaborator OTHER_GOV -
Hellenic Red Cross Hospital
collaborator OTHER -
Junior Doctors Network-Hellas
lead OTHER
Principal Investigators
-
Konstantinos Roditis, MD, MSc · JDN-Hellas / Department of Vascular Surgery, Hellenic Red Cross Hospital
-
Dimitrios Mavros, MD, MSc, PhD · Department of Vascular Surgery, Andreas Papandreou General Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-09-10
- Primary Completion
- 2016-05-14
- Completion
- 2016-06-10
Countries
- Greece
Study Locations
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