The Russian Multicenter Observational Study "Evaluation of the HDQ for the Diagnosis of Hemorrhoidal Disease ( HDQ )
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 725
- 试验地点
- 1
- 主要终点
- Sensitivity of the HDQ for Screening
研究概览
简要总结
Currently in Russia there is no available self-evaluating tools with appropriate diagnostic accuracy for screening of patients with haemorrhoids. Therefore, the primary objective of this study is to evaluate a new patient specific questionnaire (HDQ) with appropriate sensitivity and specificity to use for screening of patients with haemorrhoids in Russia. Once evaluated, the HDQ will be used in clinical practice for wider screening of haemorrhoids in population and for increasing patients' awareness of the disease and prompting them to seek professional advice.
Secondary objectives of the study are to describe a prevalence of haemorrhoids among patients in the study and to describe a prevalence of the symptoms of haemorrhoids among patients in the study
详细描述
Main parameters (primary outcomes) to be evaluated in the study are:
- sensitivity of the HDQ for screening of patients with haemorrhoids;
- specificity of the HDQ for screening of patients with haemorrhoids;
Additional parameters (secondary outcomes) in the study are:
- Prevalence rate of haemorrhoids among study population established by physicians basing on the results of the objective examination;
- Prevalence of the symptoms of haemorrhoids among patients in the study
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •The patient came to visit a coloproctologist
- •Male or female aged over 18 years
- •Signed informed consent form to participate in the study has been obtained
- •Absence of conditions requiring emergency medical care.
- •The patient is not taking VAD for at least 1 month before the date on inclusion to the study
排除标准
- •Confirmed or suspected malignant tumor
- •Diagnosed coloproctological disease at the time of inclusion
- •Severe somatic disorders (of heart and blood vessels, lungs, kidneys, pancreas, or liver), associated with decompensation of organ functions
- •Mental disorders
- •Presence of contraindications for examination
结局指标
主要结局
Sensitivity of the HDQ for Screening
时间窗: 1 month
Number of Participants with a false negative screening
Specificity of the HDQ for Screening
时间窗: 1 month
Number of Participants with a True Positive Screening
次要结局
- Prevalence Rate of Haemorrhoids Among Study Population(1 month)
- Prevalence of the Symptoms of Haemorrhoids Among Patients in the Study(1 month)