The Russian Multicenter Observational Study "Evaluation of the HDQ for the Diagnosis of Hemorrhoi… (NCT04943666) | Clinical Trial Compass
CompletedNot Applicable
The Russian Multicenter Observational Study "Evaluation of the HDQ for the Diagnosis of Hemorrhoidal Disease ( HDQ )
Russia725 participantsStarted 2021-07-12
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.