Skip to main content
OpenTrials
Completed

NCT Number: NCT03091790

Mesh Type in Ventral Hernia Repair

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ventral Hernia Hernia Hernia, Abdominal Hernia, Ventral Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UT Health at Lyndon B. Johnson General Hospital

Houston, Texas, 77026, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Synthetic Mesh

Device

Synthetic mesh used during open ventral hernia repair

Biologic Mesh

Device

Biologic mesh used during open ventral hernia repair

Primary outcomes

  1. Complication free at 1 year post-operative

    Time frame: 1 year after surgery

    Complication defined as hernia recurrence, chronic wound complications including mesh infection, and reoperation

Secondary outcomes

  1. 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

  2. Dindo-clavien complications

    Time frame: Pre-operative, 1 month after surgery, 1 year and 3 years after surgery

    Grade I to V

  3. 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

  4. Cost

    Time frame: 1 year and 3 years after surgery

    charges for all patient visits, admissions, and procedures

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Mar 27, 2017
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.