HEMOVAR Study on Hemorrhoids and Varicose Veins

Официальное название

Prospective Evaluation of the Association Between Hemorrhoids and Lower Extremity Varicose Veins Using Doppler Ultrasound (HEMOVAR Study)

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Correlation between Hemorrhoidal Disease and Lower Extremity Venous Insufficiency [Срок оценки: Baseline (single visit)]

Вторичные конечные точки (1)

• Correlation between Hemorrhoid Grade and Severity of Venous Insufficiency [Срок оценки: Baseline (single visit)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Turkey (Türkiye) · 1 центр

• Aydin Adnan Menderes University Hospital — Aydin

Публикации

• Salnikova LE, Khadzhieva MB, Kolobkov DS. Biological findings from the PheWAS catalog: focus on connective tissue-related disorders (pelvic floor dysfunction, abdominal hernia, varicose veins and hemorrhoids). Hum Genet. 2016 Jul;135(7):779-95. doi: 10.1007/s00439-016-1672-8. Epub 2016 Apr 28. PMID 27126235
• Ekici U, Kartal A, Ferhatoglu MF. Association Between Hemorrhoids and Lower Extremity Chronic Venous Insufficiency. Cureus. 2019 Apr 19;11(4):e4502. doi: 10.7759/cureus.4502. PMID 31249764
• Holdstock JM, Dos Santos SJ, Harrison CC, Price BA, Whiteley MS. Haemorrhoids are associated with internal iliac vein reflux in up to one-third of women presenting with varicose veins associated with pelvic vein reflux. Phlebology. 2015 Mar;30(2):133-9. doi: 10.1177/0268355514531952. Epub 2014 Apr 22. PMID 24755923

Идентификаторы

NCT: NCT07317492 · HEMOVAR-ADU-2025-01 · 2025/299-24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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