Tacking Mesh Versus Self-fixating Mesh for Inguinal Hernia Repair

• ClinicalTrials.gov Identifier: NCT03247985
• Recruitment Status: Completed
• First Posted: August 14, 2017
• Results First Posted: November 17, 2017
• Last Update Posted: June 15, 2018
• Sponsor: Mayo Clinic
• Information provided by (Responsible Party): David R. Farley, Mayo Clinic

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hernia, Inguinal	Device: PROLENE Polypropylene Tacking Mesh; Device: ProGrip Self-fixating Mesh	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Randomized Prospective Single-Blinded Study of Totally Extra Peritoneal Inguinal Hernia Repair: Tacking Mesh Versus Self-fixating Mesh
• Study Start Date: June 2013
• Actual Primary Completion Date: November 30, 2015
• Actual Study Completion Date: November 30, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Pain Score at Baseline [ Time Frame: baseline ]
   Participants were asked to rate their level of pain on a Likert scale (0 through 5; 0=no pain, 5=severe pain).
2. Pain Score at One Week [ Time Frame: 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).
3. Pain Score at Four Weeks [ Time Frame: 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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Minnesota

Mayo Clinic

Rochester, Minnesota, United States, 55905-0001

Sponsors and Collaborators

Mayo Clinic

Investigators

• Principal Investigator: David Farley; Mayo Clinic

More Information

• Responsible Party: David R. Farley, Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT03247985
• Other Study ID Numbers: 13-003616
• First Posted: August 14, 2017
• Results First Posted: November 17, 2017
• Last Update Posted: June 15, 2018
• Last Verified: May 2018

• 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

Keywords provided by David R. Farley, Mayo Clinic:

Mesh; Repair; Peritoneal

Additional relevant MeSH terms:

Hernia; Hernia, Inguinal; Pathological Conditions, Anatomical; Hernia, Abdominal