Risk Factors of Venous Thromboembolism After Incisional Ventral Hernia Repair.

Venous Thromboembolism Clinical Trial

Official title:

Risk Factors of Venous Thromboembolism After Incisional Ventral Hernia Repair

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05439187
• Other study ID #: 140-14/22
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: January 31, 2020

Study information

• Verified date: June 2022
• Source: Pirogov Russian National Research Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Aim of our study is to find frequency and risk factors for venous thromboembolism development in patients who underwent surgery for incisional ventral hernia. There were 240 patients enrolled in our retrospective observational cohort study. Included patients were operated for incisional hernia in Saveljev University Surgery Clinic from January 2018 to December 2019. Compression duplex ultrasound of lower legs veins was performed in 2-4 days after surgery for all participants. The primary endpoint was the occurrence of the venous thromboembolism event, including pulmonary embolism.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: January 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• operated for incisional hernia in Saveljev University Surgery Clinic No Exclusion Criteria.

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Incisional Hernia
• Thromboembolism
• Venous Thromboembolism

Intervention

Procedure:
• hernia repair
Open or laparoscopic hernia repair with mesh placement.

Locations

Country	Name	City	State
Russian Federation	Pirogov Russian National Research Medical University	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Pirogov Russian National Research Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	venous thromboembolism	Screening ultrasound in the postoperative period was aimed at looking for signs of deep vein thrombosis. The imaged vessels included the common femoral, great saphenous, superficial femoral, deep femoral, popliteal, posterior tibial, and peroneal veins of both lower extremities. The presence of a thrombotic process in the vein was evidenced by the rigidity of its walls during compression by the sensor, the presence of hyperechoic inclusions, and the impossibility of visualizing blood flow during color mapping.	was performed with median 3 days (min 1 day, max 7 days, interquartile range 2-4 days) after surgery