Comparison of Self-Fixating vs Non-Fixating Hernia Mesh

NCT ID: NCT02062775

Last Updated: 2019-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

285 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2017-10-10

Brief Summary

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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

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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.

Conditions

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Inguinal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Self-Fixating Hernia Mesh

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

Group Type ACTIVE_COMPARATOR

Use of self-fixating mesh for inguinal hernia repair

Intervention Type PROCEDURE

Parietex ProGrip will be used to repair inguinal hernia

Absorbable tacks may be used in hernias >2cm

Intervention Type PROCEDURE

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

Non-Fixating Hernia Mesh

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

Group Type PLACEBO_COMPARATOR

Use of non-fixating mesh for inguinal hernia repair

Intervention Type PROCEDURE

Parietex Anatomic mesh will be used to repair inguinal hernias.

Interventions

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Use of self-fixating mesh for inguinal hernia repair

Parietex ProGrip will be used to repair inguinal hernia

Intervention Type PROCEDURE

Use of non-fixating mesh for inguinal hernia repair

Parietex Anatomic mesh will be used to repair inguinal hernias.

Intervention Type PROCEDURE

Absorbable tacks may be used in hernias >2cm

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

Intervention Type PROCEDURE

Other Intervention Names

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Parietex ProGrip Parietex Anatomic

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic - MITG

INDUSTRY

Sponsor Role collaborator

Endeavor Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Linn, MD

Role: PRINCIPAL_INVESTIGATOR

Endeavor Health

Locations

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NorthShore University HealthSystem

Evanston, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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EH13-356

Identifier Type: -

Identifier Source: org_study_id

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