Varicose Veins of Lower LimbHEMOVARNCT07317492
HEMOVAR Study on Hemorrhoids and Varicose Veins
An observational study of Varicose Veins of Lower Limb and Hemorrhoids, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Varicose Veins of Lower Limb, Hemorrhoids
- How many people
- 400 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Dec 2025to 31 Dec 2026
- How long will I take part?
- 10 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients presenting to the general surgery proctology outpatient clinic with hemorrhoidal disease or other benign non-hemorrhoidal proctologic conditions.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Aydin Adnan Menderes University Hospital
Aydin, Efeler, 09100
Akay Edizsoy, MD, +905066332767, akayedizsoy@adu.edu.tr
About this study
Official title: Prospective Evaluation of the Association Between Hemorrhoids and Lower Extremity Varicose Veins Using Doppler Ultrasound (HEMOVAR Study)
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.
Read the detailed 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.
- Conditions
- Varicose Veins of Lower Limb, Hemorrhoids
- Keywords
- Hemorrhoids, Varicose Veins, Venous Insufficiency, Doppler Ultrasound, Venous Reflux, Proctology, Pelvic Congestion Syndrome, Prospective Observational Study, Varicocele, HEMOVAR Study
- Medical subject headings
- Hemorrhoids, Varicose Veins, Venous Insufficiency, Varicocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (single visit)
Secondary outcomes (1)
Correlation between Hemorrhoid Grade and Severity of Venous Insufficiency
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.
Measured: Baseline (single visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start19 Dec 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Varicose Veins of Lower LimbStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 10 Days
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akay Edizsoy, Aydin Adnan Menderes University
- Investigators
- Akay Edizsoy, Assist Prof., Study chair, Aydin Adnan Menderes University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07317492
- Sponsor's protocol ID
- HEMOVAR-ADU-2025-01
- Other IDs
- 2025/299-24
- Acronym
- HEMOVAR
- Status last verified
- Apr 2026
- First submitted
- 16 Dec 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared outside of anonymized aggregate analyses.
Publications
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.
PubMed 27126235Ekici 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.
PubMed 31249764Holdstock 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.
PubMed 24755923
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the Association Between Hemorrhoids and Lower Extremity Varicose Veins Using Doppler Ultrasound (HEMOVAR Study)
- ClinicalTrials.gov ID
- NCT07317492
- Acronym / sponsor ID
- HEMOVAR / HEMOVAR-ADU-2025-01
- Conditions
- Varicose Veins of Lower Limb, Hemorrhoids
- Keywords
- Hemorrhoids, Varicose Veins, Venous Insufficiency, Doppler Ultrasound, Venous Reflux, Proctology, Pelvic Congestion Syndrome, Prospective Observational Study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 19 Dec 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 10 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients presenting to the general surgery proctology outpatient clinic with hemorrhoidal disease or other benign non-hemorrhoidal proctologic conditions.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between Hemorrhoidal Disease and Lower Extremity Venous Insufficiency
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.
1 secondary outcome
Correlation between Hemorrhoid Grade and Severity of Venous Insufficiency
Time frame: Baseline (single visit)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Background: PubMed 27126235Salnikova 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.
- Background: PubMed 31249764Ekici 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.
- Background: PubMed 24755923Holdstock 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared outside of anonymized aggregate analyses.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Akay Edizsoy, Assist Prof. study chair
Aydin Adnan Menderes University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Varicose Veins of Lower Limb and Hemorrhoids, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Akay Edizsoy, MD (+905066332767, akayedizsoy@adu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between Hemorrhoidal Disease and Lower Extremity Venous Insufficiency (time frame: Baseline (single visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07317492, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.