HEMOVAR Study on Hemorrhoids and Varicose Veins
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAydin Adnan Menderes University
About this trial
The HEMOVAR Study is a prospective observational study designed to evaluate the association between hemorrhoidal disease and lower extremity varicose veins. A total of 400 adult patients presenting to the general surgery proctology outpatient clinic of Aydın Adnan Menderes University Hospital will be included. The study will consist of two groups: 200 patients diagnosed with hemorrhoids and 200 patients with other non-hemorrhoidal benign proctologic conditions serving as controls.
All participants will undergo routine clinical evaluation and demographic data collection. Cardiovascular surgeons will voluntarily perform physical examination and Doppler ultrasonography of the lower extremities to assess venous insufficiency and varicose veins. No experimental intervention or treatment will be applied. The study will not require any consumable materials and will not impose any additional financial burden on the hospital, patients, or the national health insurance system. The primary outcome is the prevalence of lower extremity venous insufficiency in patients with hemorrhoids compared with controls.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years or older
Patients presenting to the general surgery proctology outpatient clinic of Aydın Adnan Menderes University Hospital
Patients diagnosed with hemorrhoidal disease or other non-hemorrhoidal benign proctologic conditions
Ability to understand the study procedures and provide written informed consent
Disqualifiers
Patients younger than 18 years
History of lower extremity varicose vein surgery, endovenous ablation, or sclerotherapy
Presence of systemic venous disorders such as portal hypertension or liver cirrhosis
Pregnant women
Trial population
Adult patients presenting to the general surgery proctology outpatient clinic with hemorrhoidal disease or other benign non-hemorrhoidal proctologic conditions.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
400 Participants
are grouped into 2 trial groupsGroup A: Hemorrhoid Group
Group B: Control Group
Trial outcomes
Primary outcomes
1
Correlation between Hemorrhoidal Disease and Lower Extremity Venous Insufficiency
The correlation between the presence of hemorrhoidal disease (yes/no) and lower extremity venous insufficiency will be assessed using color Doppler ultrasonography. Venous insufficiency will be defined as the presence of venous reflux lasting ≥0.5 seconds in superficial veins or ≥1.0 second in deep veins. The outcome will be expressed as the percentage of patients with Doppler-confirmed venous insufficiency in each study group.
Time frame
Baseline (single visit)Secondary outcomes
1
Correlation between Hemorrhoid Grade and Severity of Venous Insufficiency
The correlation between hemorrhoid grade (Grade I-IV, assessed by clinical examination) and the severity of lower extremity venous insufficiency will be evaluated. Venous severity will be assessed using the CEAP clinical classification determined by Doppler ultrasonography. The outcome will be analyzed using correlation coefficients between hemorrhoid grade and CEAP class.
Time frame
Baseline (single visit)Sponsors and contacts
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Source ClinicalTrials.gov