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Tacking Mesh Versus Self-fixating Mesh for Inguinal Hernia Repair

Primary Purpose

Hernia, Inguinal

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PROLENE Polypropylene Tacking Mesh
ProGrip Self-fixating Mesh
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia, Inguinal focused on measuring Mesh, Repair, Peritoneal

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleDoes not accept 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.

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

PROLENE Polypropylene Tacking Mesh

ProGrip Self-fixating Mesh

Arm Description

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

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

Outcomes

Primary Outcome Measures

Mean Operative Time
Length of time needed to complete surgery.
Number of Participants With Early Postoperative Complications
Any complication which occurred within 30 days after the operation.

Secondary Outcome Measures

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).
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).
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).

Full Information

First Posted
August 10, 2017
Last Updated
May 17, 2018
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03247985
Brief Title
Tacking Mesh Versus Self-fixating Mesh for Inguinal Hernia Repair
Official Title
Randomized Prospective Single-Blinded Study of Totally Extra Peritoneal Inguinal Hernia Repair: Tacking Mesh Versus Self-fixating Mesh
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
November 30, 2015 (Actual)
Study Completion Date
November 30, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Inguinal
Keywords
Mesh, Repair, Peritoneal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PROLENE Polypropylene Tacking Mesh
Arm Type
Active Comparator
Arm Description
Participants will be randomized to Tacking Mesh for their inguinal hernia surgery.
Arm Title
ProGrip Self-fixating Mesh
Arm Type
Active Comparator
Arm Description
Participants will be randomized to Self-fixing mesh for their inguinal hernia surgery
Intervention Type
Device
Intervention Name(s)
PROLENE Polypropylene Tacking Mesh
Intervention Description
Prolene mesh is a polypropylene plastic mesh (10 x 15 cm) implant fixed with titanium tacks
Intervention Type
Device
Intervention Name(s)
ProGrip Self-fixating Mesh
Intervention Description
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
Primary Outcome Measure Information:
Title
Mean Operative Time
Description
Length of time needed to complete surgery.
Time Frame
First incision to closure, approximately one hour
Title
Number of Participants With Early Postoperative Complications
Description
Any complication which occurred within 30 days after the operation.
Time Frame
Within 30 days
Secondary Outcome Measure Information:
Title
Pain Score at Baseline
Description
Participants were asked to rate their level of pain on a Likert scale (0 through 5; 0=no pain, 5=severe pain).
Time Frame
baseline
Title
Pain Score at One Week
Description
Participants were asked to rate their level of pain on a Likert scale (0 through 5; 0=no pain, 5=severe pain).
Time Frame
One Week Postoperative
Title
Pain Score at Four Weeks
Description
Participants were asked to rate their level of pain on a Likert scale (0 through 5; 0=no pain, 5=severe pain).
Time Frame
Four Weeks Postoperative

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Farley
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905-0001
Country
United States

12. IPD Sharing Statement

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Tacking Mesh Versus Self-fixating Mesh for Inguinal Hernia Repair

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