N/A
N=38
Tacking Mesh Versus Self-fixating Mesh for Inguinal Hernia Repair
Hernia, Inguinal
Bottom Line
View on ClinicalTrials.gov: NCT03247985 ↗Enrolled (actual)
38
Serious AEs
7.9%
Results posted
Nov 2017
Primary outcome: Primary: Mean Operative Time — 69; 84; 40; 66 minutes — p=0.17
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PROLENE Polypropylene Tacking Mesh (Device); ProGrip Self-fixating Mesh (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Mayo Clinic
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Operative Time |
69; 84; 40; 66 | 0.17 |
| PRIMARY Number of Participants With Early Postoperative Complications |
2; 1; 1; 1; 1; 0 | — |
| SECONDARY Pain Score at Baseline |
1.13; 1.5 | — |
| SECONDARY Pain Score at One Week |
1.1; 0.8 | 0.02 sig |
| SECONDARY Pain Score at Four Weeks |
0.1; 0.3 | — |
Summary
Investigators are testing whether tacking mesh or self-fixating mesh used for inguinal hernia repair makes any difference in short-term pain or return to normal activities following the operation. Other studies have shown no significant difference in hernia recurrence rate when metal tacks are not used to hold the mesh in place.
Eligibility Criteria
Inclusion Criteria
- All patients regardless of sex or age who were diagnosed with a inguinal hernia and underwent a totally extraperitoneal (TEP) inguinal hernia repair at the Mayo Clinic in Rochester, Minnesota from June 2013 - June 2014.
Exclusion Criteria
- Patients who did not elect to undergo a hernia repair or who elected to undergo a different type of hernia repair instead of a TEP procedure.
Data sourced from ClinicalTrials.gov (NCT03247985). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.