HEMOVAR Study on Hemorrhoids and Varicose Veins

NCT07317492 | Recruiting

• 2 other identifiers: HEMOVAR-ADU-2025-012025/299-24
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemorrhoids; Varicose Veins of Lower Limb

Keywords

Hemorrhoids; Varicose Veins; Venous Insufficiency; Doppler Ultrasound; Venous Reflux; Proctology; Pelvic Congestion Syndrome; Prospective Observational Study; Varicocele; HEMOVAR Study

Outcome Measures

Primary Outcomes (1)

• Correlation between Hemorrhoidal Disease and Lower Extremity Venous Insufficiency

  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.

  Baseline (single visit)

Secondary Outcomes (1)

• Correlation between Hemorrhoid Grade and Severity of Venous Insufficiency

  Baseline (single visit)

Study Arms (2)

Hemorrhoid Group

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

Control Group

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients presenting to the general surgery proctology outpatient clinic with hemorrhoidal disease or other benign non-hemorrhoidal proctologic conditions.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Aydin Adnan Menderes University Hospital

Aydin, Efeler, 09100, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Hemorrhoids; Varicose Veins; Venous Insufficiency; Varicocele

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Akay Edizsoy, Assist Prof.

  Aydin Adnan Menderes University, School of Medicine

  STUDY CHAIR

Central Study Contacts

Akay Edizsoy, MD

CONTACT

+905066332767; akayedizsoy@adu.edu.tr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of General Surgery

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: January 5, 2026
• Study Start: December 19, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)