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临床试验/NCT07317492
NCT07317492招募中不适用

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

Aydin Adnan Menderes University1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2025年12月19日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
400
试验地点
1
主要终点
Correlation between Hemorrhoidal Disease and Lower Extremity Venous Insufficiency

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Correlation between Hemorrhoidal Disease and Lower Extremity Venous Insufficiency

时间窗: 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.

次要结局

  • Correlation between Hemorrhoid Grade and Severity of Venous Insufficiency(Baseline (single visit))

研究者

发起方
Aydin Adnan Menderes University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Akay Edizsoy

Assistant Professor of General Surgery

Aydin Adnan Menderes University

研究点 (1)

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