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

March 4, 2026 updated by: Servier Russia

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

725

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russia
      • Moscow, Russia
        • National Medical and Surgical Center. N.I. Pirogov

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

consecutive patients seeking help from a coloproctologist Limit: 450 characters.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of the HDQ for Screening
Time Frame: 1 month
Number of Participants with a false negative screening
1 month
Specificity of the HDQ for Screening
Time Frame: 1 month
Number of Participants with a True Positive Screening
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence Rate of Haemorrhoids Among Study Population
Time Frame: 1 month
- to describe a prevalence of haemorrhoids among patients in the study established by physicians basing on the results of the objective examination;
1 month
Prevalence of the Symptoms of Haemorrhoids Among Patients in the Study
Time Frame: 1 month
prevalence of the symptoms of haemorrhoids among patients in the study: patients with prolapsed hemorrhoids
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Servier Russia

Investigators

  • Principal Investigator: Yuriy Stoyko, Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2021

Primary Completion (Actual)

November 1, 2022

Study Completion (Actual)

December 22, 2023

Study Registration Dates

First Submitted

June 21, 2021

First Submitted That Met QC Criteria

June 21, 2021

First Posted (Actual)

June 29, 2021

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IC4-05682-063-RUS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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