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

Haemorrhoids Clinical Trial

— HDQ  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04943666
• Other study ID #: IC4-05682-063-RUS
• Status: Recruiting
• Start date: July 12, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: October 2022
• Source: Servier Russia
• Contact: Olga Linnik
• Phone: +7 495 9370700
• Email: olga.linnik[@]servier.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: December 1, 2022
• Est. primary completion date: November 1, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Haemorrhoids
• Hemorrhoids

Intervention

Other:
• Hemorrhoid Disease Questionnaire
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.

Locations

Country	Name	City	State
Russian Federation	National Medical and Surgical Center. N.I. Pirogov	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Servier Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sensitivity of the HDQ for screening of patients with haemorrhoids	Objective examination by physicians will be made that is required to determine the sensitivity of the patient's HDQ.	1 month
Primary	specificity of the HDQ for screening of patients with haemorrhoids;	Objective examination by physicians will be made that is required to determine the specificity of the patient's HDQ	1 month
Secondary	Prevalence rate of haemorrhoids among study population established by physicians basing on the results of the objective examination;	- to describe a prevalence of haemorrhoids among patients in the study	1 month
Secondary	Prevalence of the symptoms of haemorrhoids among patients in the study	- to describe a prevalence of the symptoms of haemorrhoids among patients in the study	1 month