Tacking Mesh Versus Self-fixating Mesh for Inguinal Hernia Repair

NCT03247985 | Completed Results FDA Device

• 1 other identifier: 13-003616
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Hernia, Inguinal

Keywords

Mesh; Repair; Peritoneal

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Pain Score at Baseline

  baseline

• Pain Score at One Week

  One Week Postoperative

• Pain Score at Four Weeks

  Four Weeks Postoperative

Study Arms (2)

PROLENE Polypropylene Tacking Mesh

ACTIVE COMPARATOR

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

Device: PROLENE Polypropylene Tacking Mesh

ProGrip Self-fixating Mesh

ACTIVE COMPARATOR

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

Device: ProGrip Self-fixating Mesh

Interventions

PROLENE Polypropylene Tacking Mesh DEVICE

Prolene mesh is a polypropylene plastic mesh (10 x 15 cm) implant fixed with titanium tacks

PROLENE Polypropylene Tacking Mesh

ProGrip Self-fixating Mesh DEVICE

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

ProGrip Self-fixating Mesh

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905-0001, United States

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The small sample size limits the power to reflect statistical differences. This study had a large number of bilateral repairs reflecting the inherent referral bias of our practice.

Results Point of Contact

• Title: Dr. David R. Farley
• Organization: Mayo Clinic

farley.david@mayo.edu

507-284-7565

Study Officials

• David Farley

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 10, 2017
• First Posted: August 14, 2017
• Study Start: June 1, 2013
• Primary Completion: November 30, 2015
• Study Completion: November 30, 2015
• Last Updated: June 15, 2018
• Results First Posted: November 17, 2017

Record last verified: 2018-05

Locations

US (1)