Inguinal Hernia
Conditions
Brief summary
The purpose of this study is to determine if self-fixating polyester mesh will have lower incidence of chronic postoperative pain and recurrence than non-fixating polyester mesh when used for laparoscopic inguinal hernia repair.
Detailed description
This is a randomized, blinded comparison of self-gripping mesh and standard polyester mesh for laparoscopic, primary inguinal hernia repair performed in a Totally ExtraPeritoneal (TEP) fashion.
Interventions
PROCEDUREUse of self-fixating mesh for inguinal hernia repair
Parietex ProGrip will be used to repair inguinal hernia
PROCEDUREUse of non-fixating mesh for inguinal hernia repair
Parietex Anatomic mesh will be used to repair inguinal hernias.
PROCEDUREAbsorbable tacks may be used in hernias >2cm
Patients randomized to the Parietex ProGrip study group will be further randomized to either receive absorbable tacks or no tacks if the hernia measures \>2cm
Sponsors
Medtronic - MITG
Endeavor Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \> 18 years * ASA Classification I, II, III * scheduled for elective TEP inguinal hernia repair
Exclusion criteria
* ASA Classification IV or greater * needing emergency surgery * known history of narcotic dependence * undergoing bilateral inguinal or combined umbilical hernia repair * undergoing other procedures during same anesthetic * undergoing recurrent inguinal hernia repair
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Chronic postoperative pain | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of hernia recurrence | 1 year |
Other
| Measure | Time frame |
|---|---|
| Post-Op adverse events related to mesh | 1 year |
| Post-Op quality of life and pain scores | 1 year |
Countries
United States
Outcome results
None listed