Risk Factors of Venous Thromboembolism After Incisional Ventral Hernia Repair.

• Sponsor: Pirogov Russian National Research Medical University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05439187
• Collaborator: (none)
• Enrollment: 240
• Location: 1
• Actual Duration (Months): 25
• Patients Per Site Per Month: 9.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Incisional Hernia; Venous Thromboembolism	Procedure: hernia repair

Study Design

• Study Type: Observational
• Actual Enrollment: 240 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Risk Factors of Venous Thromboembolism After Incisional Ventral Hernia Repair
• Actual Study Start Date: Jan 1, 2018
• Actual Primary Completion Date: Dec 31, 2019
• Actual Study Completion Date: Jan 31, 2020

Outcome Measures

Primary Outcome Measures

1. venous thromboembolism [was performed with median 3 days (min 1 day, max 7 days, interquartile range 2-4 days) after surgery]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pirogov Russian National Research Medical University	Moscow		Russian Federation	117997

Sponsors and Collaborators

• Pirogov Russian National Research Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Igor Zolotukhin, Professor, Pirogov Russian National Research Medical University
• ClinicalTrials.gov Identifier: NCT05439187
• Other Study ID Numbers: 140-14/22
• First Posted: Jun 30, 2022
• Last Update Posted: Jun 30, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Igor Zolotukhin, Professor, Pirogov Russian National Research Medical University: hernia repair; thromboprophylaxis
• Additional relevant MeSH terms: Thromboembolism; Venous Thromboembolism; Hernia; Hernia, Ventral; Incisional Hernia

Study Results

No Results Posted as of Jun 30, 2022