Trial Outcomes & Findings for The Russian Multicenter Observational Study "Evaluation of the HDQ for the Diagnosis of Hemorrhoidal Disease ( HDQ ) (NCT NCT04943666)

Results Overview

Number of Participants with a false negative screening

Recruitment status

COMPLETED

Target enrollment

725 participants

Primary outcome timeframe

1 month

Results posted on

2026-03-05

Participant Flow

Participant milestones

Participant milestones
Measure	Consecutive Patients Seeking Help From a Coloproctologist consecutive patients seeking help from a coloproctologist and meeting inclusion criteria
Overall Study STARTED	725
Overall Study COMPLETED	725
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Consecutive Patients Seeking Help From a Coloproctologist n=725 Participants consecutive patients seeking help from a coloproctologist and meeting inclusion criteria
Age, Continuous	44.3 years STANDARD_DEVIATION 13.6 • n=725 Participants
Sex: Female, Male Female	372 Participants n=725 Participants
Sex: Female, Male Male	353 Participants n=725 Participants
Region of Enrollment Russia	725 Participants n=725 Participants

PRIMARY outcome

Timeframe: 1 month

Number of Participants with a false negative screening

Outcome measures

Outcome measures
Measure	Consecutive Patients Seeking Help From a Coloproctologist n=725 Participants consecutive patients seeking help from a coloproctologist and meeting inclusion criteria
Sensitivity of the HDQ for Screening	627 Participants

PRIMARY outcome

Timeframe: 1 month

Number of Participants with a True Positive Screening

Outcome measures

Outcome measures
Measure	Consecutive Patients Seeking Help From a Coloproctologist n=725 Participants consecutive patients seeking help from a coloproctologist and meeting inclusion criteria
Specificity of the HDQ for Screening	549 Participants

SECONDARY outcome

Timeframe: 1 month

\- to describe a prevalence of haemorrhoids among patients in the study established by physicians basing on the results of the objective examination;

Outcome measures

Outcome measures
Measure	Consecutive Patients Seeking Help From a Coloproctologist n=725 Participants consecutive patients seeking help from a coloproctologist and meeting inclusion criteria
Prevalence Rate of Haemorrhoids Among Study Population	275 Participants

SECONDARY outcome

Timeframe: 1 month

Population: The prevalence rates of clinical symptoms of hemorrhoids were assessed using only patients with diagnosed hemorrhoids from the FAS population

prevalence of the symptoms of haemorrhoids among patients in the study: patients with prolapsed hemorrhoids

Outcome measures

Outcome measures
Measure	Consecutive Patients Seeking Help From a Coloproctologist n=725 Participants consecutive patients seeking help from a coloproctologist and meeting inclusion criteria
Prevalence of the Symptoms of Haemorrhoids Among Patients in the Study	480 Participants

Adverse Events

Consecutive Patients Seeking Help From a Coloproctologist

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Olga linnik

Servier

Phone: 8-495-93707-00

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place