HaemorrhoidsHDQNCT04943666
The Russian Multicenter Observational Study "Evaluation of the HDQ for the Diagnosis of Hemorrhoidal Disease ( HDQ )
An observational study of Haemorrhoids, run by Servier Russia at 1 site in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Haemorrhoids
- What is being tested?
- Hemorrhoid Disease Questionnaire
- How many people
- 725 participants
- Where
- 1 siteRussia
- Study dates
- 12 Jul 2021to 22 Dec 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: consecutive patients seeking help from a coloproctologist Limit: 450 characters.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the detailed description
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
- Conditions
- Haemorrhoids
- Being tested
- Hemorrhoid Disease Questionnaire
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemorrhoid Disease QuestionnaireOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of the HDQ for Screening
Number of Participants with a false negative screening
Measured: 1 month
Specificity of the HDQ for Screening
Number of Participants with a True Positive Screening
Measured: 1 month
Secondary outcomes (2)
Prevalence Rate of Haemorrhoids Among Study Population
- to describe a prevalence of haemorrhoids among patients in the study established by physicians basing on the results of the objective examination;
Measured: 1 month
Prevalence of the Symptoms of Haemorrhoids Among Patients in the Study
prevalence of the symptoms of haemorrhoids among patients in the study: patients with prolapsed hemorrhoids
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start12 Jul 2021
- Primary completion1 Nov 2022
- Study completion22 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HaemorrhoidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 725 participants (actual)
Sponsor and investigators
- Lead sponsor
- Servier Russia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuriy Stoyko, Professor, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04943666
- Sponsor's protocol ID
- IC4-05682-063-RUS
- Acronym
- HDQ
- Status last verified
- Apr 2024
- First submitted
- 21 Jun 2021
- Last updated
- 5 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Russian Multicenter Observational Study "Evaluation of the HDQ for the Diagnosis of Hemorrhoidal Disease ( HDQ )
- ClinicalTrials.gov ID
- NCT04943666
- Acronym / sponsor ID
- HDQ / IC4-05682-063-RUS
- Conditions
- Haemorrhoids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 725 participants (actual)
- Lead sponsor
- Servier RussiaIndustry (pharma, biotech, devices)
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 22 Dec 2023 (actual)
- First posted
- 29 Jun 2021 (actual)
- Results
- Posted 5 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- consecutive patients seeking help from a coloproctologist Limit: 450 characters.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemorrhoid Disease Questionnairea 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. | Other | – |
Primary outcome
Sensitivity of the HDQ for Screening
Time frame: 1 month
Number of Participants with a false negative screening
Specificity of the HDQ for Screening
Time frame: 1 month
Number of Participants with a True Positive Screening
2 secondary outcomes
Prevalence Rate of Haemorrhoids Among Study Population
Time frame: 1 month
Prevalence of the Symptoms of Haemorrhoids Among Patients in the Study
Time frame: 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuriy Stoyko, Professor principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Haemorrhoids, run by Servier Russia at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of the HDQ for Screening (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.