Mesh Type in Ventral Hernia Repair

Ventral Hernia Clinical Trial

Official title:

Mesh Type in Ventral Hernia Repair

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03091790
• Other study ID #: HSC-MS-16-0936
• Status: Completed
• Phase: N/A
• Start date: March 27, 2017
• Est. completion date: July 31, 2021

Study information

• Verified date: June 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: July 31, 2021
• Est. primary completion date: July 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient scheduled for open ventral hernia repair at LBJ General Hospital

Exclusion Criteria:

• Active infection
• Patient unlikely to survive with the next 2 years based upon surgeon judgment (i.e. metastatic cancer, end-stage cirrhosis)
• Patient surgeon would not normally place a prosthetic (e.g. planned second surgery such as ostomy takedown)
• Patient unlikely to follow-up (i.e. no phone)

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Ventral Hernia

Intervention

Device:
• Synthetic Mesh
Synthetic mesh used during open ventral hernia repair
• Biologic Mesh
Biologic mesh used during open ventral hernia repair

Locations

Country	Name	City	State
United States	UT Health at Lyndon B. Johnson General Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication free at 1 year post-operative	Complication defined as hernia recurrence, chronic wound complications including mesh infection, and reoperation	1 year after surgery
Secondary	Complication free at 3 years post-operative	Complication defined as hernia recurrence, chronic wound complications including mesh infection, and reoperation	3 years after surgery
Secondary	Dindo-clavien complications	Grade I to V	Pre-operative, 1 month after surgery, 1 year and 3 years after surgery
Secondary	Patient centered outcomes	includes patient satisfaction, cosmetic satisfaction, modified assessment scale	Pre-operative, 1 month after surgery, 1 year and 3 years after surgery
Secondary	Cost	charges for all patient visits, admissions, and procedures	1 year and 3 years after surgery