Risk Factors of Venous Thromboembolism After Incisional Ventral Hernia Repair.

Risk Factors of Venous Thromboembolism After Incisional Ventral Hernia Repair

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.

Study Overview

• Status: Completed
• Conditions: Venous Thromboembolism; Incisional Hernia
• Intervention / Treatment: Procedure: hernia repair

• Study Type: Observational
• Enrollment (Actual): 240

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 117997
    • Pirogov Russian National Research Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients of Saveljev University Surgery Clinic, Moscow

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Pirogov Russian National Research Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ACTUAL): December 31, 2019
• Study Completion (ACTUAL): January 31, 2020

Study Registration Dates

• First Submitted: May 23, 2022
• First Submitted That Met QC Criteria: June 27, 2022
• First Posted (ACTUAL): June 30, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 30, 2022
• Last Update Submitted That Met QC Criteria: June 27, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: thromboprophylaxis; hernia repair
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Postoperative Complications; Embolism and Thrombosis; Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Thromboembolism; Venous Thromboembolism; Hernia, Ventral; Incisional Hernia
• Other Study ID Numbers: 140-14/22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No