Tacking Mesh Versus Self-fixating Mesh for Inguinal Hernia Repair

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2015-11-30

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.

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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.

Conditions

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Hernia, Inguinal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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PROLENE Polypropylene Tacking Mesh

Participants will be randomized to Tacking Mesh for their inguinal hernia surgery.

Group Type ACTIVE_COMPARATOR

PROLENE Polypropylene Tacking Mesh

Intervention Type DEVICE

Prolene mesh is a polypropylene plastic mesh (10 x 15 cm) implant fixed with titanium tacks

ProGrip Self-fixating Mesh

Participants will be randomized to Self-fixing mesh for their inguinal hernia surgery

Group Type ACTIVE_COMPARATOR

ProGrip Self-fixating Mesh

Intervention Type DEVICE

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

Interventions

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PROLENE Polypropylene Tacking Mesh

Prolene mesh is a polypropylene plastic mesh (10 x 15 cm) implant fixed with titanium tacks

Intervention Type DEVICE

ProGrip Self-fixating Mesh

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

Intervention Type DEVICE

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.