NCT04943666

The Russian Multicenter Observational Study "Evaluation of the HDQ for the Diagnosis of Hemorrhoidal Disease ( HDQ )

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 725 (actual)
• Sponsor: Servier Russia · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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

Conditions

• Haemorrhoids

Interventions

Type	Name	Description
OTHER	Hemorrhoid 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.

Timeline

• Start date: 2021-07-12
• Primary completion: 2022-11-01
• Completion: 2023-12-22
• First posted: 2021-06-29
• Last updated: 2026-03-05
• Results posted: 2026-03-05

Locations

1 site across 1 country: Russia