Pre-Surgery Assessing HCV, HBV, HIV Status and Revealing During Consultation With Anesthesiologist
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 363
- 试验地点
- 2
- 主要终点
- Feasibility of HCV, HBV, HIV testing
研究概览
简要总结
The aim of the study is to assess the feasibility of HCV, HBV, HIV testing (according to the national guidelines) during consultation with Anesthesiologist before a planned surgery in Lariboisiere Hospital, Paris, France. The feasibility will be the number of tested patients divided by the number of patients who should have been tested according to the national guidelines (for each virus).
详细描述
The aim of the study is to assess the feasibility of HCV, HBV, HIV testing during consultation with Anesthesiologist before a planned surgery in Lariboisiere Hospital, Paris, France.
The national guidelines recommend at least one HIV testing during life and, more recently, one HCV testing during life to eradicate HCV infection. HBV testing is recommended in patients coming from high prevalence countries, IVDU, prisoners, patients with multiple sexual partners.
The feasibility will be the number of tested patients divided by the number of patients who should have been tested according to the national guidelines (for each virus).
HIV testing will use finger-stick whole blood (FSB) INSTI® HIV-1 & HIV-2 Rapid Antibody Test FSB (BioLytical TM Laboratories Inc., Richmond, B.C., Canada), with a sensitivity 99% [96.3-99.7] and a specificity 99.3%.
HCV testing will use finger-stick whole blood (FSB) Oraquick® HCV test, with a sensitivity and a specificity 99.1 and 100% respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient ≥ 18 years-old
- •planned surgery in Lariboisiere Hospital, Paris, France
- •able to give written informed consent for testing
- •proposed to be tested for HIV and HCV if no previous testing found in the medical record
- •proposed to be tested for HBV if the patient belong to a high-risk group: high prevalence area (Asia, sub-Saharan Africa, French Indies, East and South Europe, North-Africa, Middle-East, India, Pakistan, South-America), IVDU, prisoners, unprotected sexual intercourses.
排除标准
- •patient < 18 years-old
- •emergency surgery
- •unable to give written informed consent for testing: psychiatric diseases, neurologic diseases, ...
- •a previous testing for HIV and HCV found in the medical record and no obvious risk factor after previous testing
- •the patient does not belong to a high-risk group for HBV
结局指标
主要结局
Feasibility of HCV, HBV, HIV testing
时间窗: Day 0 : during initial consultation, up to 1 hour
Feasibility (assessed by the number of tested patients divided by the number of patients who should have been tested according to the national guidelines (for each virus)) of HCV, HBV, HIV testing during consultation with Anesthesiologist before a planned surgery in Lariboisiere Hospital, Paris, France
次要结局
- Acceptability of HCV, HBV, HIV testing(Day 0 : during initial consultation, up to 1 hour)
- Acceptability of being treated (for each virus) for the patients who have been tested positive for HCV and/or HBV and/or HIV, by questionning(during Day 0, after the initial consultation)