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Prospective Trial Comparing Two Different Polypropylene Meshes for Inguinal Hernias

NCT01825187 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2022-06-14

Study results available
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Summary

The purpose of this research study is to measure the clinical effectiveness of two different polypropylene meshes used for laparoscopic inguinal hernias by evaluating subjects' length of hospital stay, perioperative complications, recurrence rate, pain score, comfort level and postoperative quality of life. A secondary goal of the study is to evaluate the ease of use and time it takes surgical residents to place the mesh and perform the surgery using these two different meshes.

Conditions

  • Hernia, Inguinal

Interventions

DEVICE

ULTRAPRO Mesh

Patients who are randomized to this group will received ULTRAPRO Mesh for their hernia repair

DEVICE

3DMAX

Patients who are randomized to this group will receive 3DMAX mesh for their hernia repair

OTHER

Evaluation

To evaluate the ease of use and time it takes residents to place and perform the surgery using these two different meshes.

Sponsors & Collaborators

  • New Hanover Regional Medical Center

    collaborator OTHER

  • South East Area Health Education Center, Wilmington, NC

    lead OTHER

Principal Investigators

  • William W Hope, MD · South East Area Health Education Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2020-08-31
Completion
2020-08-31

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 NCT01825187 on ClinicalTrials.gov