HEMOVAR Study on Hemorrhoids and Varicose Veins

Aydin Adnan Menderes University

Status

Enrolling

Conditions

Varicose Veins of Lower Limb

Hemorrhoids

Study type

Observational

Funder types

Other

Identifiers

NCT07317492

2025/299-24 (Other Identifier)

HEMOVAR-ADU-2025-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment

400 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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