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

NCT04943666 | Completed Results

• 1 other identifier: IC4-05682-063-RUS
• Study Type: observational
• Target: 725
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Haemorrhoids

Outcome Measures

Primary Outcomes (2)

• Sensitivity of the HDQ for Screening

  Number of Participants with a false negative screening

  1 month

• Specificity of the HDQ for Screening

  Number of Participants with a True Positive Screening

  1 month

Secondary Outcomes (2)

• Prevalence Rate of Haemorrhoids Among Study Population

  1 month

• Prevalence of the Symptoms of Haemorrhoids Among Patients in the Study

  1 month

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Confirmed or suspected malignant tumor
• 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

Sponsors & Collaborators

• Servier Russia: lead

Study Sites (1)

National Medical and Surgical Center. N.I. Pirogov

Moscow, Russia

Location

MeSH Terms

Conditions

Hemorrhoids

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Olga linnik
• Organization: Servier

olga.linnik@servier.com

8-495-93707-00

Study Officials

• Yuriy Stoyko, Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: June 29, 2021
• Study Start: July 12, 2021
• Primary Completion: November 1, 2022
• Study Completion: December 22, 2023
• Last Updated: March 5, 2026
• Results First Posted: March 5, 2026

Record last verified: 2024-04

Locations

RU (1)