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

NCT ID: NCT04943666

Last Updated: 2022-10-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 450 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-12
• Study Completion Date: 2022-12-01

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

Conditions

Haemorrhoids

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Servier Russia

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yuriy Stoyko, Professor

Role: PRINCIPAL_INVESTIGATOR

Locations

National Medical and Surgical Center. N.I. Pirogov

Moscow, , Russia

Site Status: RECRUITING

Countries

Russia

Central Contacts

Olga Linnik

Role: CONTACT

olga.linnik@servier.com

+7 495 9370700 ext. 1316

Facility Contacts

Yuriy Stoyko, Proff.

Role: primary

ystoyko@mail.ru

+7 985 784 88 60

Other Identifiers

IC4-05682-063-RUS

Identifier Type: -

Identifier Source: org_study_id