Overview

This trial has been completed.

Conditions physical function, pain, hernia, wound infection, postoperative complication, recurrence
Treatments polypropylene mesh, infinit® ptfe mesh (wl gore)
Phase phase 4
Sponsor University of Roma La Sapienza
Start date September 2009
End date September 2010
Trial size 70 participants
Trial identifier NCT01141335, DS-002

Summary

To evaluate the safety and efficacy of the Lichtenstein's hernioplasty using Infinit® PTFE Mesh, and to compare it with the traditional Lichtenstein procedure performed with polypropylene mesh.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver)
Primary purpose treatment
Arm
(Experimental)
A Lichtenstein tension-free hernioplasty is performed using PTFE mesh
infinit® ptfe mesh (wl gore)
A Lichtenstein tension-free hernioplasty is performed using a PTFE mesh will be fixed by sutures in PTFE 2/0.
(Active Comparator)
A Lichtenstein tension-free hernioplasty is performed using polypropylene mesh
polypropylene mesh
A Lichtenstein tension-free hernioplasty is performed using a polypropylene mesh will be fixed by sutures in Polypropylene 2/0.

Primary Outcomes

Measure
post-hernioplasty acute pain
time frame: 24 hours

Secondary Outcomes

Measure
physical function
time frame: 24 hours
postoperative acute discomfort
time frame: 24 hours
wound infection
time frame: 7 days
postoperative complication
time frame: from 24 hours to 5 years
recurrence
time frame: from 1 months to 5 years
mesh shrinkage
time frame: 14 days
post-hernioplasty acute pain
time frame: 72 hours
post-hernioplasty acute pain
time frame: 7 days
post-hernioplasty acute pain
time frame: 14 days
post-hernioplasty chronic pain
time frame: 1 months
post-hernioplasty chronic pain
time frame: 3 months
post-hernioplasty chronic pain
time frame: 6 months
post-hernioplasty chronic pain
time frame: 1 year
post-hernioplasty chronic pain
time frame: 2 years
post-hernioplasty chronic pain
time frame: 3 years
post-hernioplasty chronic pain
time frame: 4 years
post-hernioplasty chronic pain
time frame: 5 years
physical function
time frame: 72 hours
physical function
time frame: 7 days
physical function
time frame: 14 days
physical function
time frame: 1 months
physical function
time frame: 3 months
physical function
time frame: 6 months
physical function
time frame: 1 year
physical function
time frame: 2 years
physical function
time frame: 3 years
physical function
time frame: 4 years
physical function
time frame: 5 years
postoperative acute discomfort
time frame: 72 hours
postoperative acute discomfort
time frame: 14 days
postoperative chronic discomfort
time frame: 1 months
postoperative chronic discomfort
time frame: 3 months
postoperative chronic discomfort
time frame: 6 months
postoperative chronic discomfort
time frame: 1 year
postoperative chronic discomfort
time frame: 2 years
postoperative chronic discomfort
time frame: 3 years
postoperative chronic discomfort
time frame: 4 years
postoperative chronic discomfort
time frame: 5 years
postoperative acute and chronic discomfort
time frame: 7 days
wound infection
time frame: 14 days
wound infection
time frame: 1 months
wound infection
time frame: 3 months
wound infection
time frame: 6 months
wound infection
time frame: 1 year
wound infection
time frame: 2 years
wound infection
time frame: 3 years
wound infection
time frame: 4 years
wound infection
time frame: 5 years
mesh shrinkage
time frame: 1 months
mesh shrinkage
time frame: 3 months
mesh shrinkage
time frame: 6 months
mesh shrinkage
time frame: 1 years
mesh shrinkage
time frame: 2 years
mesh shrinkage
time frame: 3 years
mesh shrinkage
time frame: 4 years
mesh shrinkage
time frame: 5 years

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - >18 <65 years of age - Diagnosis of Unilateral inguinal hernia - Able to provide written consent - BMI < 35 - ASA I-II patients - Non-complicated primary inguinal hernia performed in non-emergency setting and repaired with a Lichtenstein's hernioplasty - Informed consent Exclusion Criteria: - Recurrent hernias - Incarcerated hernia - BMI > 35 - ASA III-IV patients - Any condition preventing a correct evaluation of pain (non-cooperative patient, blind patient, drug addicted) - Hypersensitivity to any drug in study - Patients with an intra-operative findings of different pathology will be excluded from the study

Additional Information

Official title Lichtenstein's Repair of Inguinal Hernia With Polypropylene Mesh Versus Infinit® PTFE Mesh, a Prospective Randomized, Double-blind, Controlled Trial
Principal investigator Francesco Saverio Mari, Dr.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by University of Roma La Sapienza.