Tacking Mesh Versus Self-fixating Mesh for Inguinal Hernia Repair

Study Overview
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Brief Summary
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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.

Detailed Description
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Participants will be placed into two groups. One group of participants will have mesh tacked into place for their hernia repairs. The other group will have self-fixating mesh into place. Both groups will have a piece of mesh that will widely cover the hernia defect. Before surgery, the participant will be asked to rate discomfort on a 0-10 scale. Zero stands for no pain and 10 is the worst pain they can imagine. Investigators will record information about general medical condition, medications and activity level. During the operation information will be recorded about the pain medicines the participant may receive. In the recovery room the participant will be asked to rate their pain on the 0-10 scale and more information will be recorded about any additional pain medicines that they may receive and assess activity level. Following surgery, Investigators will contact the participants by survey to obtain more information about pain level, medication use, and activity level.

Official Title
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Randomized Prospective Single-Blinded Study of Totally Extra Peritoneal Inguinal Hernia Repair: Tacking Mesh Versus Self-fixating Mesh

Conditions
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Hernia, Inguinal

Intervention / Treatment
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* Device: PROLENE Polypropylene Tacking Mesh
* Device: ProGrip Self-fixating Mesh


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PROLENE Polypropylene Tacking Mesh<br>Participants will be randomized to Tacking Mesh for their inguinal hernia surgery. | Device: PROLENE Polypropylene Tacking Mesh<br>* Prolene mesh is a polypropylene plastic mesh (10 x 15 cm) implant fixed with titanium tacks<br>|
| Active Comparator: ProGrip Self-fixating Mesh<br>Participants will be randomized to Self-fixing mesh for their inguinal hernia surgery | Device: ProGrip Self-fixating Mesh<br>* ProGrip™ self-fixating mesh is a tack-free fixation mesh for use in open & laparoscopic hernia repairs. It is composed of absorbable Monofilament Polylactic Acid micro grips on one surface integrated with a lightweight Monofilament Polyethylene Terephthalate. The micro grips act as a kind of Velcro to the soft tissue surfaces resulting in self-fixation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Operative Time | Length of time needed to complete surgery. | First incision to closure, approximately one hour | 
| Number of Participants With Early Postoperative Complications | Any complication which occurred within 30 days after the operation. | Within 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score at Baseline | Participants were asked to rate their level of pain on a Likert scale (0 through 5; 0=no pain, 5=severe pain). | baseline | 
| Pain Score at One Week | Participants were asked to rate their level of pain on a Likert scale (0 through 5; 0=no pain, 5=severe pain). | One Week Postoperative | 
| Pain Score at Four Weeks | Participants were asked to rate their level of pain on a Likert scale (0 through 5; 0=no pain, 5=severe pain). | Four Weeks Postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mesh, Repair, Peritoneal