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

Recruiting

• Conditions: Haemorrhoids

• Registration Number: NCT04943666
• Lead Sponsor: Servier Russia

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

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 Timeline

• Study First Submitted: 2021-06-21
• Study First Submitted QC: 2021-06-21
• Study First Posted: 2021-06-29
• Study Start: 2021-07-12
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-25
• Last Update Posted: 2022-10-26
• Primary Completion: 2022-11-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
sensitivity of the HDQ for screening of patients with haemorrhoids	1 month	Objective examination by physicians will be made that is required to determine the sensitivity of the patient's HDQ.
specificity of the HDQ for screening of patients with haemorrhoids;	1 month	Objective examination by physicians will be made that is required to determine the specificity of the patient's HDQ

Secondary Outcome Measures

Name	Time	Method
Prevalence rate of haemorrhoids among study population established by physicians basing on the results of the objective examination;	1 month	- to describe a prevalence of haemorrhoids among patients in the study
Prevalence of the symptoms of haemorrhoids among patients in the study	1 month	- to describe a prevalence of the symptoms of haemorrhoids among patients in the study

Trial Locations

Locations (1)

National Medical and Surgical Center. N.I. Pirogov; 🇷🇺 Moscow, Russian Federation