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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
Main parameters (primary outcomes) to be evaluated in the study are:
Additional parameters (secondary outcomes) in the study are:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence Rate of Haemorrhoids Among Study Population | - to describe a prevalence of haemorrhoids among patients in the study established by physicians basing on the results of the objective examination; | 1 month |
| Prevalence of the Symptoms of Haemorrhoids Among Patients in the Study |
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Inclusion Criteria:
Exclusion Criteria:
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consecutive patients seeking help from a coloproctologist Limit: 450 characters.
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| Name | Affiliation | Role |
|---|---|---|
| Yuriy Stoyko, Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Medical and Surgical Center. N.I. Pirogov | Moscow | Russia |
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| ID | Title | Description |
|---|---|---|
| FG000 | Consecutive Patients Seeking Help From a Coloproctologist | consecutive patients seeking help from a coloproctologist and meeting inclusion criteria |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Consecutive Patients Seeking Help From a Coloproctologist | consecutive patients seeking help from a coloproctologist and meeting inclusion criteria |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sensitivity of the HDQ for Screening | Number of Participants with a false negative screening | Posted | Count of Participants | Participants | 1 month |
|
|
1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Consecutive Patients Seeking Help From a Coloproctologist | consecutive patients seeking help from a coloproctologist and meeting inclusion criteria |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Olga linnik | Servier | 8-495-93707-00 | olga.linnik@servier.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 28, 2021 | Apr 22, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 28, 2021 | Apr 22, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006484 | Hemorrhoids |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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prevalence of the symptoms of haemorrhoids among patients in the study: patients with prolapsed hemorrhoids |
| 1 month |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
| Primary | Specificity of the HDQ for Screening | Number of Participants with a True Positive Screening | Posted | Count of Participants | Participants | 1 month |
|
|
|
| Secondary | Prevalence Rate of Haemorrhoids Among Study Population | - to describe a prevalence of haemorrhoids among patients in the study established by physicians basing on the results of the objective examination; | Posted | Count of Participants | Participants | 1 month |
|
|
|
| Secondary | Prevalence of the Symptoms of Haemorrhoids Among Patients in the Study | prevalence of the symptoms of haemorrhoids among patients in the study: patients with prolapsed hemorrhoids | The prevalence rates of clinical symptoms of hemorrhoids were assessed using only patients with diagnosed hemorrhoids from the FAS population | Posted | Count of Participants | Participants | 1 month |
|
|
|
| 0 |
| 725 |
| 0 |
| 725 |
| 0 |
| 725 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |