N/A N=75 Randomized Treatment

Prospective Trial Comparing Two Different Polypropylene Meshes for Inguinal Hernias

Hernia, Inguinal

Bottom Line

View on ClinicalTrials.gov: NCT01825187 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2022

Primary outcome: Primary: Inguinal Hernia Mesh Insertion Times — 9.76; 8.70 Minutes — p=0.523

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: ULTRAPRO Mesh (Device); 3DMAX (Device); Evaluation (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: South East Area Health Education Center, Wilmington, NC
Primary completion: Aug 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Inguinal Hernia Mesh Insertion Times	9.76; 8.70	0.523
SECONDARY NASA TLX Survey Index Scores	7.63; 8.67; 6.67; 7.00; 7.46; 8.00	0.371

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.

Eligibility Criteria

Inclusion Criteria

Subjects undergoing laparoscopic repair for the treatment of either single or bilateral inguinal hernias
All surgical residents at New Hanover Regional Medical Center

Exclusion Criteria

Subjects requiring emergency surgery
Pregnant subjects
Subjects under the age of 18 years of age

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01825187). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.