NCT03247985

Tacking Mesh Versus Self-fixating Mesh for Inguinal Hernia Repair

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

• Hernia, Inguinal

Interventions

Type	Name	Description
DEVICE	PROLENE Polypropylene Tacking Mesh	Prolene mesh is a polypropylene plastic mesh (10 x 15 cm) implant fixed with titanium tacks
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

Timeline

• Start date: 2013-06-01
• Primary completion: 2015-11-30
• Completion: 2015-11-30
• First posted: 2017-08-14
• Last updated: 2018-06-15
• Results posted: 2017-11-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study