Inguinal Hernia
Conditions
Keywords
Inguinal hernia, polypropylene, Biodesign IHM, lichtenstein
Brief summary
Aim is to evaluate outcomes of inguinal hernia repair incorporating the standard Lichtenstein (open) repair using Biodesign IHM in a double blind (physician evaluator and patient will be blinded), randomized, prospective comparative study with polypropylene mesh. Primary outcome is recurrence at 1 year. Hernia recurrence will be confirmed via ultrasound or CT scan.
Interventions
DEVICEBiodesign IHM
Biodesign IHM is placed to reinforce the hernia repair
DEVICEPolypropylene mesh
Polypropylene mesh is used to reinforce the hernia repair.
Sponsors
Cook Biotech Incorporated
MED Institute, Incorporated
Cook Group Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age * Diagnosis of Unilateral inguinal hernia repair * Able to provide written consent
Exclusion criteria
* Incarcerated hernia * Allergic or religious beliefs that disallow porcine material * Previous hernia repair on the designated hernia site * Class IV or V anesthesia requirements * Bowel obstruction * Peritonitis * Life expectancy \< 3 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Patients With Inguinal Hernia Recurrence | 1 year |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Biodesign IHM Graft Biodesign Inguinal Hernia Matrix (IHM) | 50 |
| Polypropylene Mesh Synthetic polypropylene mesh | 50 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 11 | 9 |
| Overall Study | Physician Decision | 5 | 0 |
Baseline characteristics
| Characteristic | Biodesign IHM Graft | Polypropylene Mesh | Total |
|---|---|---|---|
| Age, Continuous | 64 years | 59 years | 61.5 years |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 50 Participants | 50 Participants | 100 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 18 / 45 | 15 / 50 |
| serious Total, serious adverse events | 7 / 45 | 5 / 50 |
Outcome results
Primary
Number of Patients With Inguinal Hernia Recurrence
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Biodesign IHM Graft | Number of Patients With Inguinal Hernia Recurrence | 3 participants |
| Polypropylene Mesh | Number of Patients With Inguinal Hernia Recurrence | 0 participants |
Comparison: Two-sided Fisher's exact testp-value: 0.11Fisher Exact