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Comparison of Self-Fixating vs Non-Fixating Hernia Mesh

NCT02062775 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 285

Last updated 2019-09-11

No results posted yet for this study

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.

Conditions

  • Inguinal Hernia

Interventions

PROCEDURE

Use of self-fixating mesh for inguinal hernia repair

Parietex ProGrip will be used to repair inguinal hernia

PROCEDURE

Use of non-fixating mesh for inguinal hernia repair

Parietex Anatomic mesh will be used to repair inguinal hernias.

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

Sponsors & Collaborators

  • Medtronic - MITG

    collaborator INDUSTRY

  • Endeavor Health

    lead OTHER

Principal Investigators

  • John Linn, MD · Endeavor Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2017-10-10
Completion
2017-10-10

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02062775 on ClinicalTrials.gov