Clinical Trial: Mesh Type in Ventral Hernia Repair
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Mesh Type in Ventral Hernia Repair
Brief Summary: Ventral hernias are common following abdominal surgery. Currently, there is no equipoise on when synthetic and biologic meshes should be used. Among open ventral hernia repairs, half are repaired using biologic mesh while half are repaired using synthetic mesh. The investigators hypothesize that biologic mesh as opposed to synthetic mesh repair of open ventral hernia repair is associated with decreased risk of major complications one year after surgery.
Detailed Summary:
Sponsor: The University of Texas Health Science Center, Houston
Current Primary Outcome: Complication free at 1 year post-operative [ Time Frame: 1 year after surgery ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Complication free at 3 years post-operative [ Time Frame: 3 years after surgery ]Complication defined as hernia recurrence, chronic wound complications including mesh infection, and reoperation
- Dindo-clavien complications [ Time Frame: Pre-operative, 1 month after surgery, 1 year and 3 years after surgery ]Grade I to V
- Patient centered outcomes [ Time Frame: Pre-operative, 1 month after surgery, 1 year and 3 years after surgery ]includes patient satisfaction, cosmetic satisfaction, modified assessment scale
- Cost [ Time Frame: 1 year and 3 years after surgery ]charges for all patient visits, admissions, and procedures
Original Secondary Outcome: Same as current
Information By: The University of Texas Health Science Center, Houston
Dates:
Date Received: March 21, 2017
Date Started: March 27, 2017
Date Completion: March 31, 2022
Last Updated: April 4, 2017
Last Verified: April 2017