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.
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
- Conditions the study is for
- Varicose Veins, Superficial Venous Thrombosis, Day Surgery
- 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.
China1 site
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120
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.
- Conditions
- Varicose Veins, Superficial Venous Thrombosis, Day Surgery
- 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 group | Role | What they receive |
|---|---|---|
| SVT group | Varicose vein patients complicated with superficial thrombophlebitis | |
| Non-SVT group | Patients had varicose vein only |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative deep venous thrombosis
deep venous thrombosis after surgery
Measured: Events within one week after surgery
saphenous nerve injury
saphenous nerve injury after surgery
Measured: Events during surgery
subcutaneous induration
subcutaneous induration after surgery
Measured: Events within one week after surgery
Secondary outcomes (5)
varicose veins recurrence
VV recurred during follow-up
Measured: recurrence within 12 months follow-up after surgery
superficial venous thrombosis formation
superficial venous thrombosis formatted during follow-up
Measured: Events within 12 months follow-up after surgery
deep venous thrombosis
deep venous thrombosis event during follow-up
Measured: Events within 12 months follow-up after surgery
skin burns
skin burns after operation
Measured: Events during surgery
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.
- First posted19 May 2022
- Study start10 Jun 2022 (estimated)
- Primary completion10 Jun 2024 (estimated)
- Study completion10 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Varicose VeinsStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 699 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huang Kai, doctor, Study chair, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Daytime Surgery in Varicose Veins Patients With and Without Superficial Venous Thrombosis: a Propensity Score Matched Analysis
- ClinicalTrials.gov ID
- NCT05380895
- Acronym / sponsor ID
- SYSKY-2022-013-01
- Conditions
- Varicose Veins, Superficial Venous Thrombosis, Day Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 699 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 10 Jun 2022 (estimated)
- Primary completion
- 10 Jun 2024 (estimated)
- Study completion
- 10 Jun 2025 (estimated)
- First posted
- 19 May 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 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SVT group | – | –Varicose vein patients complicated with superficial thrombophlebitis |
| Non-SVT group | – | –Patients had varicose vein only |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- VV patients with the CEAP grade of C2-C5;
- At the age 18 to 75;
- Treated by day surgery
Key exclusion criteria (6 listed)
- 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;
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
postoperative deep venous thrombosis
Time frame: Events within one week after surgery
deep venous thrombosis after surgery
saphenous nerve injury
Time frame: Events during surgery
saphenous nerve injury after surgery
subcutaneous induration
Time frame: Events within one week after surgery
subcutaneous induration after surgery
5 secondary outcomes
varicose veins recurrence
Time frame: recurrence within 12 months follow-up after surgery
superficial venous thrombosis formation
Time frame: Events within 12 months follow-up after surgery
deep venous thrombosis
Time frame: Events within 12 months follow-up after surgery
skin burns
Time frame: Events during surgery
bleeding requiring intervention
Time frame: Events during surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Derived from this study: PubMed 37537563Xu 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.
- Individual participant dataSharing planned: No. Clinical treatment information that does not design patient privacy
Related trials for Varicose Veins
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
Not yet recruiting
Mindfulness Intervention on Minimally Invasive Vascular Surgery
Anxiety, Pain
Active, not recruitingObservational study
Pain During Heat Treatment for Lower Extremity Varicose Veins: Radiofrequency vs. Microwave
Lower Extremity Varicose Veins, Radiofrequency Ablation
Not yet recruiting
Phenotyping Rehabilitation for Improving Frailty, Functional Capacity
Varicose Veins
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.
Huang Kai, doctor study chair
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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 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.