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

NCT05380895 | Unknown

• 1 other identifier: SYSKY-2022-013-01
• Study Type: observational
• Target: 699
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Varicose Veins; Superficial Venous Thrombosis; Day Surgery

Outcome Measures

Primary Outcomes (3)

• postoperative deep venous thrombosis

  deep venous thrombosis after surgery

  Events within one week after surgery

• saphenous nerve injury

  saphenous nerve injury after surgery

  Events during surgery

• subcutaneous induration

  subcutaneous induration after surgery

  Events within one week after surgery

Secondary Outcomes (5)

• varicose veins recurrence

  recurrence within 12 months follow-up after surgery

• superficial venous thrombosis formation

  Events within 12 months follow-up after surgery

• deep venous thrombosis

  Events within 12 months follow-up after surgery

• skin burns

  Events during surgery

• bleeding requiring intervention

  Events during surgery

Study Arms (2)

SVT group

Varicose vein patients complicated with superficial thrombophlebitis

Non-SVT group

Patients had varicose vein only

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510120, China

Location

Related Publications (1)

• 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.

  PMID: 37537563 DERIVED

MeSH Terms

Conditions

Varicose Veins

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Huang Kai, doctor

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  STUDY CHAIR

Central Study Contacts

Huang Kai, doctor

CONTACT

18820001023; huangk37@mail2.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2022
• First Posted: May 19, 2022
• Study Start: June 10, 2022
• Primary Completion: June 10, 2024
• Study Completion: June 10, 2025
• Last Updated: May 19, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)