HEMOVAR Study on Hemorrhoids and Varicose Veins

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-19

Study Completion Date

2026-04-30

Brief Summary

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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.

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Detailed Description

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The HEMOVAR Study is a single-center, prospective, cross-sectional observational investigation conducted at Aydın Adnan Menderes University Hospital. The study aims to examine the association between hemorrhoidal disease and lower extremity venous insufficiency using standardized clinical assessment and Doppler ultrasonography. Adult patients presenting to the general surgery proctology outpatient clinic will be screened for eligibility and enrolled after providing written informed consent.

Two parallel groups will be formed: patients with clinically diagnosed hemorrhoids and a control group consisting of patients with other benign non-hemorrhoidal proctologic conditions. Cardiovascular surgeons will voluntarily perform clinical examination and color Doppler ultrasonography of the lower limb venous system in all participants. Doppler parameters including the presence of venous reflux, affected venous segments, reflux duration, venous diameter, and CEAP clinical classification will be recorded. Laboratory evaluation will be limited to hemoglobin measurement. Secondary analyses will explore the coexistence of other venous disorders such as varicocele and pelvic congestion syndrome.

This study involves no experimental intervention, randomization, or invasive procedures. No consumables will be used, and there will be no additional financial burden on the hospital, patients, or the national health insurance system. The study will commence following approval by the local ethics committee, and data will be collected and analyzed in accordance with the Declaration of Helsinki and Good Clinical Practice principles.

Conditions

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Varicose Veins of Lower Limb Hemorrhoids

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Hemorrhoid Group

Adult patients (≥18 years) diagnosed with hemorrhoidal disease presenting to the general surgery proctology clinic.

No interventions assigned to this group

Control Group

Adult patients (≥18 years) with non-hemorrhoidal benign proctologic diseases presenting to the same clinic.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* Patients with known malignancy or severe comorbid conditions that could interfere with evaluation
* Refusal or inability to provide written informed consent

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No