Tacking Mesh Versus Self-fixating Mesh for Inguinal Hernia Repair

Mayo Clinic

Status: Completed

Conditions: Hernia, Inguinal

Treatments: Device: PROLENE Polypropylene Tacking Mesh; Device: ProGrip Self-fixating Mesh

Study type: Interventional

Funder types: Other

Identifiers

NCT03247985

13-003616

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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38 participants in 2 patient groups

PROLENE Polypropylene Tacking Mesh

Active Comparator group

Description:

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

Treatment:

Device: PROLENE Polypropylene Tacking Mesh

ProGrip Self-fixating Mesh

Active Comparator group

Description:

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

Treatment:

Device: ProGrip Self-fixating Mesh