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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Subcutaneous ecchymoses number 1d-postop
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years
- •CVI CEAP Class II or III
- •Informed consent signed
排除标准
- •Age <18 or >80 years
- •CVI CEAP Class I or IV (venous ulcers)
- •Allergy to adrenaline history
- •No informed consent signed
研究组 & 干预措施
Group A
Group A - great saphenous vein stripping with local adrenaline use for hemostasis
干预措施: Great saphenous vein stripping and varicectomies (Procedure)
Group A
Group A - great saphenous vein stripping with local adrenaline use for hemostasis
干预措施: Epinephrine Topical (Drug)
Group B
Group B - great saphenous vein stripping with local normal saline use for hemostasis
干预措施: Great saphenous vein stripping and varicectomies (Procedure)
Group B
Group B - great saphenous vein stripping with local normal saline use for hemostasis
干预措施: normal saline (Drug)
Group C
Group C - great saphenous vein stripping with traditional hemostatic practice
干预措施: Great saphenous vein stripping and varicectomies (Procedure)
结局指标
主要结局
Subcutaneous ecchymoses number 1d-postop
时间窗: 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
时间窗: 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
时间窗: 336 hours post-operatively
The absolute number of subcutaneous ecchymoses on the operated limb on 14th post-operative day
Subcutaneous hematomas number 1d-postop
时间窗: 24 hours post-operatively
The absolute number of subcutaneous hematomas in the operated limb on 1st post-operative day
Subcutaneous hematomas number 8d-postop
时间窗: 192 hours post-operatively
The absolute number of subcutaneous hematomas in the operated limb on 8th post-operative day
Subcutaneous hematomas number 14d-postop
时间窗: 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
时间窗: 24 hours post-operatively
The total area in mm2 of subcutaneous ecchymoses in the operated limb on 1st post-operative day
Subcutaneous hematomas total area 14d-postop
时间窗: 336 hours post-operatively
The total area in mm2 of subcutaneous hematomas in the operated limb on 14th post-operative day
Subcutaneous ecchymoses total area 8d-postop
时间窗: 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
时间窗: 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 8d-postop
时间窗: 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 1d-postop
时间窗: 24 hours post-operatively
The total area in mm2 of subcutaneous hematomas in the operated limb on 1st post-operative day
QoL-CIVIQ2 1month post-op
时间窗: 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.
QoL-SF36 preop
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)
- WBC postop(24 hours post-operatively)
- PLT preop(24 hours pre-operatively)
- PLT postop(24 hours post-operatively)
- FIB preop(24 hours pre-operatively)
- FIB postop(24 hours post-operatively)
- ESR preop(24 hours pre-operatively)
- ESR postop(24 hours post-operatively)
- CRP preop(24 hours pre-operatively)
- CRP postop(24 hours post-operatively)
- Experienced pain preop(24 hours pre-operatively)
- Experienced pain 1d-postop(24 hours post-operatively)
- Experienced pain 8d-postop(192 hours post-operatively)
- Experienced pain 14d-postop(336 hours post-operatively)
研究者
Konstantinos Roditis
MD, MSc, Chief Resident, JDN-Hellas Board Chairperson
Junior Doctors Network-Hellas