NCT02062775

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
285

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 14, 2014

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2017

Completed
Last Updated

September 11, 2019

Status Verified

September 1, 2019

Enrollment Period

4.2 years

First QC Date

February 11, 2014

Last Update Submit

September 9, 2019

Conditions

Inguinal Hernia

Outcome Measures

Primary Outcomes (1)

  • Chronic postoperative pain

    1 year

Secondary Outcomes (1)

  • Incidence of hernia recurrence

    1 year

Other Outcomes (2)

  • Post-Op adverse events related to mesh

    1 year

  • Post-Op quality of life and pain scores

    1 year

Study Arms (2)

Self-Fixating Hernia Mesh

ACTIVE COMPARATOR

Self-fixating polyester mesh will be used for laparoscopic inguinal hernia repair.

Procedure: Use of self-fixating mesh for inguinal hernia repairProcedure: Absorbable tacks may be used in hernias >2cm

Non-Fixating Hernia Mesh

PLACEBO COMPARATOR

Non-fixating polyester mesh will be used for laparoscopic hernia repair.

Procedure: Use of non-fixating mesh for inguinal hernia repair

Interventions

Use of self-fixating mesh for inguinal hernia repairPROCEDURE

Parietex ProGrip will be used to repair inguinal hernia

Also known as: Parietex ProGrip
Self-Fixating Hernia Mesh
Use of non-fixating mesh for inguinal hernia repairPROCEDURE

Parietex Anatomic mesh will be used to repair inguinal hernias.

Also known as: Parietex Anatomic
Non-Fixating Hernia Mesh
Absorbable tacks may be used in hernias >2cmPROCEDURE

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

Self-Fixating Hernia Mesh

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \> 18 years
  • ASA Classification I, II, III
  • scheduled for elective TEP inguinal hernia repair

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • John Linn, MD

    Endeavor Health

    PRINCIPAL INVESTIGATOR

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
SPONSOR

Study Record Dates

First Submitted

February 11, 2014

First Posted

February 14, 2014

Study Start

August 1, 2013

Primary Completion

October 10, 2017

Study Completion

October 10, 2017

Last Updated

September 11, 2019

Record last verified: 2019-09

Locations

US(1)