Ventral Hernia
Conditions
Brief summary
The purpose of this study is to compare clinical and patient centered outcomes of biosynthetic poly-4-hydroybutyrate meshes versus current care (synthetic polypropylene mesh or suture) for complex ventral hernia repair. The primary outcome for this study will be patients who are major complication free at 2 years postoperative. This will be a composite of hernia recurrence, reoperation, chronic wound complication, or death. Secondary outcomes include: surgical site occurences such as surgical site infection, seroma, hematoma and skin dehiscence within 90 days postoperative, emergency room visits withing 90 days postoperative, days in hospital up to 90 days postoperative, abdominal pain, and change in patient centered outcomes measured through the modified activities assessment scale (mAAS).
Interventions
PROCEDURERepair of ventral hernia using biologic mesh
Ventral hernia will be repaired using biologic mesh
PROCEDURERepair of ventral hernia using suture repair or synthetic mesh
Ventral hernia will be repaired using the current treatment methods
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients (18 years or older) with a complex ventral hernia scheduled for repair
Exclusion criteria
* Patients likely to die within 3 years (cirrhosis, terminal cancer, surgeon judgement) * Unlikely to follow-up (live out of state, unable to be reached by phone or email) * Non-English and non-Spanish speakers * Pregnant or breast-feeding patients * Allergies/hypersensitivities to tetracycline hydrochloride and kanamycin sulfate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major complication free | 2 years post-operative | A composite of hernia recurrence, reoperation, chronic wound complication, or death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clavien-Dindo complication grade | 90 days post-operative | Clavien-Dindo complication grade |
| Hospital duration | 90 days post-operative | Days in hospital composed of post-operative length of stay and readmissions |
| Emergency room visits | 90 days post-operative | Number of times ER was visited |
| Surgical site occurrences | 90 days post-operative | Surgical site infection, seroma, hematoma, and skin dehiscence |
| Post-operative abdominal pain | Day of consent and post-operatively at 1 month, 1 year and 2 years | Measured by the visual analogue scale (VAS) |
| Patient centered outcomes | Day of consent and post-operatively at 1 month, 1 year and 2 years | Abdominal wall health status (AW-HS) measured through the modified activities assessment scale (mAAS) |
| Cost Analysis | 2 years | Analysis of costs as performed from the healthcare perspective |
Countries
United States
Outcome results
None listed