Haemorrhoids
Conditions
Brief summary
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
Detailed description
Main parameters (primary outcomes) to be evaluated in the study are: 1. sensitivity of the HDQ for screening of patients with haemorrhoids; 2. specificity of the HDQ for screening of patients with haemorrhoids; Additional parameters (secondary outcomes) in the study are: 1. Prevalence rate of haemorrhoids among study population established by physicians basing on the results of the objective examination; 2. Prevalence of the symptoms of haemorrhoids among patients in the study
Interventions
OTHERHemorrhoid Disease Questionnaire
a new patient specific questionnaire (HDQ) with appropriate sensitivity and specificity to use for screening of patients with haemorrhoids in Russia 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.
Sponsors
Servier Russia
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of the HDQ for Screening | 1 month | Number of Participants with a false negative screening |
| Specificity of the HDQ for Screening | 1 month | Number of Participants with a True Positive Screening |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence Rate of Haemorrhoids Among Study Population | 1 month | \- to describe a prevalence of haemorrhoids among patients in the study established by physicians basing on the results of the objective examination; |
| Prevalence of the Symptoms of Haemorrhoids Among Patients in the Study | 1 month | prevalence of the symptoms of haemorrhoids among patients in the study: patients with prolapsed hemorrhoids |
Countries
Russia
Contacts
PRINCIPAL_INVESTIGATORYuriy Stoyko, Professor
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 44.3 years STANDARD_DEVIATION 13.6 |
| Region of Enrollment Russia | 725 Participants |
| Sex: Female, Male Female | 372 Participants |
| Sex: Female, Male Male | 353 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 725 |
| other Total, other adverse events | 0 / 725 |
| serious Total, serious adverse events | 0 / 725 |
Outcome results
None listed