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Varicose VeinsNCT05380895

Comparison of Daytime Surgery in Varicose Veins Patients With and Without Superficial Venous Thrombosis

An observational study of Varicose Veins and Superficial Venous Thrombosis, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Varicose veins of lower extremities are the most common disease in vascular surgery, and daytime surgery has gradually become the mainstream of varicose veins of lower extremities. Superficial venous thrombosis is one of the common complications of varicose veins of lower limbs. Read more about this study

Who is it for?
Ages 18 to 75 years
How many people
699 participants
Where
1 siteChina
Study dates
10 Jun 2022to 10 Jun 2025
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: This is a single center retrospective cohort study, which retrospectively analyzed the clinical data of VV patients treated in Sun Yat-sen Memorial Hospital of Sun Yat-sen University from 2015 to 2021. Doppler ultrasound, combined with clinical examination, was used in the diagnosis of SVT.

Who may be able to join

  • VV patients with the CEAP grade of C2-C5;
  • At the age 18 to 75;
  • Treated by day surgery

Who cannot join

  • Patient has a history of DVT or is suffering from DVT;
  • Patients with liver and renal failure;
  • Patients in hypercoagulable state;
  • Patients with anticoagulant therapy before operation;
  • Patients with active ulcer;
  • Patient is intolerant to foam sclerotherapy

Trial locations and contacts

1 site in 1 country.

Huang Kai, doctor contact

18820001023

huangk37@mail2.sysu.edu.cn

China1 site
  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510120

Other trials in China

About this study

Official title: Comparison of Daytime Surgery in Varicose Veins Patients With and Without Superficial Venous Thrombosis: a Propensity Score Matched Analysis

Varicose veins of lower extremities are the most common disease in vascular surgery, and daytime surgery has gradually become the mainstream of varicose veins of lower extremities. Superficial venous thrombosis is one of the common complications of varicose veins of lower limbs. Current consensus is that patients with superficial venous thrombosis should be treated with standardized anticoagulant therapy to prevent their progression to venous thrombotic disease.SVT patients need standardized anticoagulant therapy for a period of time, while DS is current mainstream treatment of VV. Will the existence of SVT affect the safety and efficacy of DS of VV, leading a need of changing the treatment strategy and carrying out anticoagulant treatment for SVT before DS on VV patients? To date, there is no research on this issue. Therefore, we conducted this study to comprehensively evaluate the safety, feasibility, perioperative and long-term efficacy of DS in VV patients complicated with SVT, and systematically compared patients who had VV only.

Read the detailed description

Varicose veins (VV) of lower extremities are common diseases in outpatient and inpatients. Approximately 25% of the world's adult population suffer from varicose veins of lower extremities, of which, the prevalence of VV in China reaches 8.9%, affecting more than 100 million people. From this, VV is a highly prevalent disease and one of the major public health problems in the world, placing huge economic and medical burden on both patients and health care.

Unlike inpatient surgery (IS), by which previous VV patients were mainly treated, Day surgery (DS), also known as ambulatory surgery,tends to exhibit higher medical efficacy and less cost of health care. Moreover, the development of endovenous treatment and sclerotherapy technology makes it feasible for clinicians to treat VV through DS. DS for VV patients can well alleviate the contradiction between the growth of medical demand and the shortage of medical resources, considering the fact that merely 4.3 beds are available per 1000 people on average in China.

Superficial venous thrombosis (SVT) of lower extremities, as a common complication of VV, is characterized by pain, erythema and usually palpable nodular mass of the diseased veins. Currently, VV still are the most common risk factor of SVT, despite SVT can exist independently. Previous studies have shown that the probability of SVT in VV patients ranges from 4% to 59%, while up to 80% of SVT patients are complicated with VV. SVT used to be considered as a self-limiting benign disease lacking in enough attention in clinical decision-making. However current researches show that SVT is closely related to the occurrence of venous thromboembolism (VTE), and especially when SVT involves the blood vessels connecting the deep venous system, the probability of VTE is as high as 18%, which seriously threatens the safety of patients. Due to the close relationship between SVT and VTE, the treatment of SVT is gaining its importance recent years. The latest guidelines of CHEST recommend 45 days of anticoagulant therapy for patients with SVT to reduce their risk of progressing to VTE, and surgery, including ligation of the great saphenofemoral joint or stripping of the superficial vein of thrombosis, is also applied in the treatment of SVT. SVT patients need standardized anticoagulant therapy for a period of time, while DS is current mainstream treatment of VV. Will the existence of SVT affect the safety and efficacy of DS of VV, leading a need of changing the treatment strategy and carrying out anticoagulant treatment for SVT before DS on VV patients? To date, there is no research on this issue.

It remains unclear whether the combination of SVT will have a negative impact on the DS of VV patients. Therefore, we conducted this study to comprehensively evaluate the safety, feasibility, perioperative and long-term efficacy of DS in VV patients complicated with SVT, and systematically compared patients who had VV only. To reduce the possible selection bias, a propensity score matching model (PSM) was used to balance the baseline data of the two groups of patients.

Medical subject headings
Varicose Veins

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05380895
Study groupRoleWhat they receive
SVT groupVaricose vein patients complicated with superficial thrombophlebitis
Non-SVT groupPatients had varicose vein only

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. postoperative deep venous thrombosis

    deep venous thrombosis after surgery

    Measured: Events within one week after surgery

  2. saphenous nerve injury

    saphenous nerve injury after surgery

    Measured: Events during surgery

  3. subcutaneous induration

    subcutaneous induration after surgery

    Measured: Events within one week after surgery

Secondary outcomes (5)
  1. varicose veins recurrence

    VV recurred during follow-up

    Measured: recurrence within 12 months follow-up after surgery

  2. superficial venous thrombosis formation

    superficial venous thrombosis formatted during follow-up

    Measured: Events within 12 months follow-up after surgery

  3. deep venous thrombosis

    deep venous thrombosis event during follow-up

    Measured: Events within 12 months follow-up after surgery

  4. skin burns

    skin burns after operation

    Measured: Events during surgery

  5. bleeding requiring intervention

    bleeding requiring intervention during operation

    Measured: Events during surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2022
  2. Study start10 Jun 2022 (estimated)
  3. Primary completion10 Jun 2024 (estimated)
  4. Study completion10 Jun 2025 (estimated)

Resources

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
Cohort
Time perspective
Retrospective
Enrolment
699 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05380895
Sponsor's protocol ID
SYSKY-2022-013-01
Status last verified
May 2022
First submitted
8 May 2022
Last updated
19 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Clinical treatment information that does not design patient privacy

Publications

  • Xu J, Xu X, Tian J, Huang M, Xia Z, Luo X, Zheng J, Huang K. Comparison of day surgery between varicose veins with and without superficial venous thrombosis below knee: a propensity score-matched analysis. BMC Cardiovasc Disord. 2023 Aug 3;23(1):387. doi: 10.1186/s12872-023-03398-2.

    PubMed 37537563

Questions about this trial

What is this clinical trial studying?

An observational study of Varicose Veins and Superficial Venous Thrombosis, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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 3 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: status not confirmed, as of the sponsor's last update on 19 May 2022. 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?

Contact Huang Kai, doctor (18820001023, huangk37@mail2.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

postoperative deep venous thrombosis (time frame: Events within one week after surgery). The study lists 3 primary outcomes in all. 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 NCT05380895, which also lists 1 linked publication.

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 19 May 2022.

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