Clinical trial NCT04943666: The Russian Multicenter Observational Study "Evaluation of the HDQ for the Diagnosis of Hemorrhoidal Disease ( HDQ )
Official title: The Russian Multicenter Observational Study "Evaluation of the HDQ for the Diagnosis of Hemorrhoidal Disease ( HDQ )
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Haemorrhoids
Lead sponsor: Servier Russia
Sponsor class: INDUSTRY
First posted: 2021-06-29
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: consecutive patients seeking help from a coloproctologist Limit: 450 characters.

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

Eligibility criteria: 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

Primary outcomes:
measure: sensitivity of the HDQ for screening of patients with haemorrhoids
timeFrame: 1 month
measure: specificity of the HDQ for screening of patients with haemorrhoids;
timeFrame: 1 month
Secondary outcomes:
measure: Prevalence rate of haemorrhoids among study population established by physicians basing on the results of the objective examination;
timeFrame: 1 month
measure: Prevalence of the symptoms of haemorrhoids among patients in the study
timeFrame: 1 month
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: National Medical and Surgical Center. N.I. Pirogov
Study officials:
name: Yuriy Stoyko, Professor
role: PRINCIPAL_INVESTIGATOR
References: