Aydin Adnan Menderes University Hospital
Aydin, Efeler, 09100, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07317492
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Aydin, Efeler, 09100, Turkey (Türkiye)
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline (single visit)
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)
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.
Contact information is provided by the study sponsor or research team.
Aydin Adnan Menderes University
Other
Prospective Evaluation of the Association Between Hemorrhoids and Lower Extremity Varicose Veins Using Doppler Ultrasound (HEMOVAR Study)
Acronym: HEMOVAR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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