Polypropylene Mesh Versus Polytetrafluoroethylene (PTFE) Mesh in Inguinal Hernia Repair

November 20, 2016 updated by: Francesco Saverio Mari, University of Roma La Sapienza

Lichtenstein's Repair of Inguinal Hernia With Polypropylene Mesh Versus Infinit® PTFE Mesh, a Prospective Randomized, Double-blind, Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00189
        • UO Oneday-day Surgery, Azienda Ospedaliera Sant'Andrea

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PTFE mesh
A Lichtenstein tension-free hernioplasty is performed using PTFE mesh
Device: 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: polypropylene mesh
A Lichtenstein tension-free hernioplasty is performed using polypropylene mesh
Device: polypropylene mesh
A Lichtenstein tension-free hernioplasty is performed using a polypropylene mesh will be fixed by sutures in Polypropylene 2/0.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
post-hernioplasty acute pain
Time Frame: 24 hours
to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), and parenteral/oral analgesic consumption in the two groups
24 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
physical function
Time Frame: 24 hours
to measure the physical function score from the SF-36 questionnaire
24 hours
postoperative acute discomfort
Time Frame: 24 hours
to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).
24 hours
wound infection
Time Frame: 7 days
to rate the wound infection risk.
7 days
postoperative complication
Time Frame: from 24 hours to 5 years
to monitor any other postoperative complication observed in the immediate, mid-term and long-term postoperative period.
from 24 hours to 5 years
recurrence
Time Frame: from 1 months to 5 years
to measure the recurrence
from 1 months to 5 years
mesh shrinkage
Time Frame: 14 days
to measure the effectiveness shrinkage of the two different mesh using Ultrasound
14 days
post-hernioplasty acute pain
Time Frame: 72 hours
to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), and parenteral/oral analgesic consumption in the two groups
72 hours
post-hernioplasty acute pain
Time Frame: 7 days
to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), and parenteral/oral analgesic consumption in the two groups
7 days
post-hernioplasty acute pain
Time Frame: 14 days
to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), and parenteral/oral analgesic consumption in the two groups
14 days
post-hernioplasty chronic pain
Time Frame: 1 months
to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), and parenteral/oral analgesic consumption in the two groups
1 months
post-hernioplasty chronic pain
Time Frame: 3 months
to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), and parenteral/oral analgesic consumption in the two groups
3 months
post-hernioplasty chronic pain
Time Frame: 6 months
to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), and parenteral/oral analgesic consumption in the two groups
6 months
post-hernioplasty chronic pain
Time Frame: 1 year
to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), and parenteral/oral analgesic consumption in the two groups
1 year
post-hernioplasty chronic pain
Time Frame: 2 years
to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), and parenteral/oral analgesic consumption in the two groups
2 years
post-hernioplasty chronic pain
Time Frame: 3 years
to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), and parenteral/oral analgesic consumption in the two groups
3 years
post-hernioplasty chronic pain
Time Frame: 4 years
to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), and parenteral/oral analgesic consumption in the two groups
4 years
post-hernioplasty chronic pain
Time Frame: 5 years
to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), and parenteral/oral analgesic consumption in the two groups
5 years
physical function
Time Frame: 72 hours
to measure the physical function score from the SF-36 questionnaire
72 hours
physical function
Time Frame: 7 days
to measure the physical function score from the SF-36 questionnaire
7 days
physical function
Time Frame: 14 days
to measure the physical function score from the SF-36 questionnaire
14 days
physical function
Time Frame: 1 months
to measure the physical function score from the SF-36 questionnaire
1 months
physical function
Time Frame: 3 months
to measure the physical function score from the SF-36 questionnaire
3 months
physical function
Time Frame: 6 months
to measure the physical function score from the SF-36 questionnaire
6 months
physical function
Time Frame: 1 year
to measure the physical function score from the SF-36 questionnaire
1 year
physical function
Time Frame: 2 years
to measure the physical function score from the SF-36 questionnaire
2 years
physical function
Time Frame: 3 years
to measure the physical function score from the SF-36 questionnaire
3 years
physical function
Time Frame: 4 years
to measure the physical function score from the SF-36 questionnaire
4 years
physical function
Time Frame: 5 years
to measure the physical function score from the SF-36 questionnaire
5 years
postoperative acute discomfort
Time Frame: 72 hours
to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).
72 hours
postoperative acute discomfort
Time Frame: 14 days
to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).
14 days
postoperative chronic discomfort
Time Frame: 1 months
to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).
1 months
postoperative chronic discomfort
Time Frame: 3 months
to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).
3 months
postoperative chronic discomfort
Time Frame: 6 months
to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).
6 months
postoperative chronic discomfort
Time Frame: 1 year
to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).
1 year
postoperative chronic discomfort
Time Frame: 2 years
to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).
2 years
postoperative chronic discomfort
Time Frame: 3 years
to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).
3 years
postoperative chronic discomfort
Time Frame: 4 years
to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).
4 years
postoperative chronic discomfort
Time Frame: 5 years
to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).
5 years
postoperative acute and chronic discomfort
Time Frame: 7 days
to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).
7 days
wound infection
Time Frame: 14 days
to rate the wound infection risk.
14 days
wound infection
Time Frame: 1 months
to rate the wound infection risk.
1 months
wound infection
Time Frame: 3 months
to rate the wound infection risk.
3 months
wound infection
Time Frame: 6 months
to rate the wound infection risk.
6 months
wound infection
Time Frame: 1 year
to rate the wound infection risk.
1 year
wound infection
Time Frame: 2 years
to rate the wound infection risk.
2 years
wound infection
Time Frame: 3 years
to rate the wound infection risk.
3 years
wound infection
Time Frame: 4 years
to rate the wound infection risk.
4 years
wound infection
Time Frame: 5 years
to rate the wound infection risk.
5 years
mesh shrinkage
Time Frame: 1 months
to measure the effectiveness shrinkage of the two different mesh using Ultrasound
1 months
mesh shrinkage
Time Frame: 3 months
to measure the effectiveness shrinkage of the two different mesh using Ultrasound
3 months
mesh shrinkage
Time Frame: 6 months
to measure the effectiveness shrinkage of the two different mesh using Ultrasound
6 months
mesh shrinkage
Time Frame: 1 years
to measure the effectiveness shrinkage of the two different mesh using Ultrasound
1 years
mesh shrinkage
Time Frame: 2 years
to measure the effectiveness shrinkage of the two different mesh using Ultrasound
2 years
mesh shrinkage
Time Frame: 3 years
to measure the effectiveness shrinkage of the two different mesh using Ultrasound
3 years
mesh shrinkage
Time Frame: 4 years
to measure the effectiveness shrinkage of the two different mesh using Ultrasound
4 years
mesh shrinkage
Time Frame: 5 years
to measure the effectiveness shrinkage of the two different mesh using Ultrasound
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Roma La Sapienza

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Luigi Masoni, Dr., Azienda Ospedaliera Sant'Andrea, Rome, Italy
  • Principal Investigator: Francesco Saverio Mari, Dr., Azienda Ospedaliera Sant'Andrea, Rome, Italy
  • Study Director: Antonio Brescia, Prof., Azienda Ospedaliera Sant'Andrea, Rome, Italy
  • Principal Investigator: Giuseppe R Nigri, Dr., Azienda Ospedaliera Sant'Andrea, Rome, Italy
  • Principal Investigator: Francesco Favi, Dr, Azienda Ospedaliera Sant'Andrea, Rome, Italy
  • Principal Investigator: Andrea Milillo, Dr., Azienda Ospedaliera Sant'Andrea, Rome, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 9, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 10, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 22, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DS-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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