N/A
N=725
The Russian Multicenter Observational Study "Evaluation of the HDQ for the Diagnosis of Hemorrhoidal Disease ( HDQ )
Haemorrhoids
Bottom Line
View on ClinicalTrials.gov: NCT04943666 ↗Enrolled (actual)
725
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Sensitivity of the HDQ for Screening — 627 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Hemorrhoid Disease Questionnaire (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Servier Russia
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity of the HDQ for Screening |
627 | — |
| PRIMARY Specificity of the HDQ for Screening |
549 | — |
| SECONDARY Prevalence Rate of Haemorrhoids Among Study Population |
275 | — |
| SECONDARY Prevalence of the Symptoms of Haemorrhoids Among Patients in the Study |
480 | — |
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
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
Data sourced from ClinicalTrials.gov (NCT04943666). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.