Tacking Mesh Versus Self-fixating Mesh for Inguinal Hernia Repair

Not Applicable

Completed

Interventions: Device: PROLENE Polypropylene Tacking Mesh
Device: ProGrip Self-fixating Mesh

Brief 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
PROLENE Polypropylene Tacking Mesh	PROLENE Polypropylene Tacking Mesh	Participants will be randomized to Tacking Mesh for their inguinal hernia surgery.
ProGrip Self-fixating Mesh	ProGrip Self-fixating Mesh	Participants will be randomized to Self-fixing mesh for their inguinal hernia surgery

Primary Outcome Measures

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

Secondary Outcome Measures

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