Varicose VeinsNCT05410912
Varicose Vein in Patients Under the Age of 40
An observational study of Varicose Veins, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
Varicose veins are a result of valvular insufficiency and presented with twisted, enlarged veins. They not only cause cosmetic concerns but also lead to limb edema, skin pigmentation/lipodermatosclerosis, and even venous ulcers. This disease affects a large percentage of the population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Varicose Veins
- What is being tested?
- Great saphenous vein stripping and ambulatory phlebectomy
- Type of treatment
- Surgery or procedure
- How many people
- 168 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients with primary great saphenous varicose veins (GSVV) and treated by great saphenous vein stripping and ambulatory phlebectomy.
Who may be able to join
- great saphenous varicose veins (GSVV) with saphenous vein reflux >0.5s.
- lower extremity venography excluding iliac vein compression;
- treated by great saphenous vein stripping and ambulatory phlebectomy.
- the patient had a minimum follow-up of five years.
Who cannot join
- secondary varicose veins (defined as varicose veins caused by deep vein thrombosis, iliac venous compression or venous injury etc.);
- small saphenous veins;
- treated by endovenous ablation/laser or sclerotherapy alone.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000
About this study
Varicose veins are a result of valvular insufficiency and presented with twisted, enlarged veins. They not only cause cosmetic concerns but also lead to limb edema, skin pigmentation/lipodermatosclerosis, and even venous ulcers. This disease affects a large percentage of the population. Although there have been several researches on the risk factors for varicose veins and the outcomes of alternative therapies , there is currently limited data focusing on varicose veins in young patients. In this case-control study, we wanted to assess the risk factors for varicose veins in patients under the age of 40, as well as their long-term results of surgery.
- Conditions
- Varicose Veins
- Being tested
- Great saphenous vein stripping and ambulatory phlebectomy
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Great saphenous vein stripping and ambulatory phlebectomyProcedure or surgery
All patients included in the study were treated with great saphenous vein stripping and ambulatory phlebectomy.
| Study group | Role | What they receive |
|---|---|---|
| The younger group | Patients who were under the age of 40 Receives: Procedure: Great saphenous vein stripping and ambulatory phlebectomy | |
| The older group | Patients who were more than 40 years old Receives: Procedure: Great saphenous vein stripping and ambulatory phlebectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative varicose veins sequelae
The sequelae of the varicose vein were assessed by Venous Clinical Severity Score (VCSS). The total score is 0~30. The higher scores mean a worse outcome.
Measured: Five years after surgery.
Postoperative quality of life
Quality of life was assessed by the Aberdeen Varicose Vein Questionnaire (AVVQ). The total score is 1~100. The higher scores mean a worse outcome.
Measured: Five years after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start1 Jan 2021
- Primary completion30 Jun 2022
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicose VeinsStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang 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
- Retrospective
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ziheng Wu, MD, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05410912
- Sponsor's protocol ID
- IIT20210662A
- Status last verified
- Sep 2024
- First submitted
- 6 Jun 2022
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Varicose Vein in Patients Under the Age of 40
- ClinicalTrials.gov ID
- NCT05410912
- Acronym / sponsor ID
- IIT20210662A
- Conditions
- Varicose Veins
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 8 Jun 2022 (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.
Varicose veins are a result of valvular insufficiency and presented with twisted, enlarged veins. They not only cause cosmetic concerns but also lead to limb edema, skin pigmentation/lipodermatosclerosis, and even venous ulcers. This disease affects a large percentage of the population. Although there have been several researches on the risk factors for varicose veins and the outcomes of alternative therapies , there is currently limited data focusing on varicose veins in young patients. In this case-control study, we wanted to assess the risk factors for varicose veins in patients under the age of 40, as well as their long-term results of surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The younger group | – | Procedure: Great saphenous vein stripping and ambulatory phlebectomyPatients who were under the age of 40 |
| The older group | – | Procedure: Great saphenous vein stripping and ambulatory phlebectomyPatients who were more than 40 years old |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with primary great saphenous varicose veins (GSVV) and treated by great saphenous vein stripping and ambulatory phlebectomy.
Key inclusion criteria (4 listed)
- great saphenous varicose veins (GSVV) with saphenous vein reflux >0.5s.
- lower extremity venography excluding iliac vein compression;
- treated by great saphenous vein stripping and ambulatory phlebectomy.
- the patient had a minimum follow-up of five years.
Key exclusion criteria (3 listed)
- secondary varicose veins (defined as varicose veins caused by deep vein thrombosis, iliac venous compression or venous injury etc.);
- small saphenous veins;
- treated by endovenous ablation/laser or sclerotherapy alone.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Great saphenous vein stripping and ambulatory phlebectomyAll patients included in the study were treated with great saphenous vein stripping and ambulatory phlebectomy. | Procedure or surgery | The older group, The younger group |
Primary outcome
Postoperative varicose veins sequelae
Time frame: Five years after surgery.
The sequelae of the varicose vein were assessed by Venous Clinical Severity Score (VCSS). The total score is 0~30. The higher scores mean a worse outcome.
Postoperative quality of life
Time frame: Five years after surgery.
Quality of life was assessed by the Aberdeen Varicose Vein Questionnaire (AVVQ). The total score is 1~100. The higher scores mean a worse outcome.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
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 3 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: status not confirmed, as of the sponsor's last update on 27 Sep 2024. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative varicose veins sequelae (time frame: Five years after surgery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Sep 2024.