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

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.

Study Overview

• Status: Completed
• Conditions: Hernia, Inguinal
• Intervention / Treatment: Device: PROLENE Polypropylene Tacking Mesh; Device: ProGrip Self-fixating Mesh

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.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905-0001
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PROLENE Polypropylene Tacking Mesh; Participants will be randomized to Tacking Mesh for their inguinal hernia surgery.	Device: PROLENE Polypropylene Tacking Mesh; Prolene mesh is a polypropylene plastic mesh (10 x 15 cm) implant fixed with titanium tacks
Active Comparator: ProGrip Self-fixating Mesh; Participants will be randomized to Self-fixing mesh for their inguinal hernia surgery	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: David Farley, Mayo Clinic

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): November 30, 2015
• Study Completion (Actual): November 30, 2015

Study Registration Dates

• First Submitted: August 10, 2017
• First Submitted That Met QC Criteria: August 10, 2017
• First Posted (Actual): August 14, 2017

Study Record Updates

• Last Update Posted (Actual): June 15, 2018
• Last Update Submitted That Met QC Criteria: May 17, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Mesh; Repair; Peritoneal
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: 13-003616

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes