Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2026-01-01 @ 9:40 PM
Study NCT ID:
NCT04943666
Status:
UNKNOWN
Last Update Posted:
2022-10-26
First Post:
2021-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Russian Multicenter Observational Study "Evaluation of the HDQ for the Diagnosis of Hemorrhoidal Disease ( HDQ )
Sponsor:
Servier Russia
Organization:
Study Overview
Official Title:
The Russian Multicenter Observational Study "Evaluation of the HDQ for the Diagnosis of Hemorrhoidal Disease ( HDQ )
Status:
UNKNOWN
Status Verified Date:
2022-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HDQ
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
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: