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NCT Number: NCT04943666

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

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

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Key information

Conditions

Haemorrhoids Cardiovascular Diseases Digestive System Diseases Gastrointestinal Diseases Hemorrhoids Intestinal Diseases Rectal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Medical and Surgical Center. N.I. Pirogov

Moscow, Russia

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hemorrhoid Disease Questionnaire

Other

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.

Primary outcomes

  1. Sensitivity of the HDQ for Screening

    Time frame: 1 month

    Number of Participants with a false negative screening

  2. Specificity of the HDQ for Screening

    Time frame: 1 month

    Number of Participants with a True Positive Screening

Secondary outcomes

  1. 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;

  2. 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

Sponsors and collaborators

Lead sponsor

Servier Russia

Industry

Registry information

Acronym: HDQ

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jun 29, 2021
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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