Back to resultsComparison of Self-Fixating vs Non-Fixating Hernia Mesh
Primary Purpose
Inguinal Hernia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Use of self-fixating mesh for inguinal hernia repair
Use of non-fixating mesh for inguinal hernia repair
Absorbable tacks may be used in hernias >2cm
Sponsored by
About this trial
This is an interventional treatment trial for Inguinal Hernia
Eligibility Criteria
Inclusion Criteria:
- > 18 years
- ASA Classification I, II, III
- scheduled for elective TEP inguinal hernia repair
Exclusion Criteria:
- ASA Classification IV or greater
- needing emergency surgery
- known history of narcotic dependence
- undergoing bilateral inguinal or combined umbilical hernia repair
- undergoing other procedures during same anesthetic
- undergoing recurrent inguinal hernia repair
Sites / Locations
- NorthShore University HealthSystem
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Self-Fixating Hernia Mesh
Non-Fixating Hernia Mesh
Arm Description
Self-fixating polyester mesh will be used for laparoscopic inguinal hernia repair.
Non-fixating polyester mesh will be used for laparoscopic hernia repair.
Outcomes
Primary Outcome Measures
Chronic postoperative pain
Secondary Outcome Measures
Incidence of hernia recurrence
Full Information
NCT ID
NCT02062775
First Posted
February 11, 2014
Last Updated
September 9, 2019
Sponsor
NorthShore University HealthSystem
Collaborators
Medtronic - MITG
1. Study Identification
Unique Protocol Identification Number
NCT02062775
Brief Title
Comparison of Self-Fixating vs Non-Fixating Hernia Mesh
Official Title
A Randomized Controlled Study of Self Fixating Mesh Versus Non Fixating Polyester Mesh for Laparoscopic Inguinal Hernia Repair
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
October 10, 2017 (Actual)
Study Completion Date
October 10, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NorthShore University HealthSystem
Collaborators
Medtronic - MITG
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine if self-fixating polyester mesh will have lower incidence of chronic postoperative pain and recurrence than non-fixating polyester mesh when used for laparoscopic inguinal hernia repair.
Detailed Description
This is a randomized, blinded comparison of self-gripping mesh and standard polyester mesh for laparoscopic, primary inguinal hernia repair performed in a Totally ExtraPeritoneal (TEP) fashion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
285 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Self-Fixating Hernia Mesh
Arm Type
Active Comparator
Arm Description
Self-fixating polyester mesh will be used for laparoscopic inguinal hernia repair.
Arm Title
Non-Fixating Hernia Mesh
Arm Type
Placebo Comparator
Arm Description
Non-fixating polyester mesh will be used for laparoscopic hernia repair.
Intervention Type
Procedure
Intervention Name(s)
Use of self-fixating mesh for inguinal hernia repair
Other Intervention Name(s)
Parietex ProGrip
Intervention Description
Parietex ProGrip will be used to repair inguinal hernia
Intervention Type
Procedure
Intervention Name(s)
Use of non-fixating mesh for inguinal hernia repair
Other Intervention Name(s)
Parietex Anatomic
Intervention Description
Parietex Anatomic mesh will be used to repair inguinal hernias.
Intervention Type
Procedure
Intervention Name(s)
Absorbable tacks may be used in hernias >2cm
Intervention Description
Patients randomized to the Parietex ProGrip study group will be further randomized to either receive absorbable tacks or no tacks if the hernia measures >2cm
Primary Outcome Measure Information:
Title
Chronic postoperative pain
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Incidence of hernia recurrence
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Post-Op adverse events related to mesh
Time Frame
1 year
Title
Post-Op quality of life and pain scores
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
> 18 years
ASA Classification I, II, III
scheduled for elective TEP inguinal hernia repair
Exclusion Criteria:
ASA Classification IV or greater
needing emergency surgery
known history of narcotic dependence
undergoing bilateral inguinal or combined umbilical hernia repair
undergoing other procedures during same anesthetic
undergoing recurrent inguinal hernia repair
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Linn, MD
Organizational Affiliation
NorthShore University HealthSystem
Official's Role
Principal Investigator
Facility Information:
Facility Name
NorthShore University HealthSystem
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparison of Self-Fixating vs Non-Fixating Hernia Mesh
We'll reach out to this number within 24 hrs