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)
240
1
25
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
  • 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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 30, 2022