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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Francesco Saverio Mari, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01141335
First received: June 9, 2010
Last updated: February 3, 2012
Last verified: June 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Physical Function
Pain
Hernia
Wound Infection
Postoperative Complication
Recurrence
 Device: polypropylene mesh
Device: Infinit® PTFE mesh (WL Gore)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Lichtenstein's Repair of Inguinal Hernia With Polypropylene Mesh Versus Infinit® PTFE Mesh, a Prospective Randomized, Double-blind, Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Chronic Pain Hernia
U.S. FDA Resources

Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:
  • post-hernioplasty acute pain [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • physical function [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    to measure the physical function score from the SF-36 questionnaire

  • postoperative acute discomfort [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).

  • wound infection [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    to rate the wound infection risk.

  • postoperative complication [ Time Frame: from 24 hours to 5 years ] [ Designated as safety issue: No ]
    to monitor any other postoperative complication observed in the immediate, mid-term and long-term postoperative period.

  • recurrence [ Time Frame: from 1 months to 5 years ] [ Designated as safety issue: No ]
    to measure the recurrence

  • mesh shrinkage [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    to measure the effectiveness shrinkage of the two different mesh using Ultrasound

  • post-hernioplasty acute pain [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    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

  • post-hernioplasty acute pain [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    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

  • post-hernioplasty acute pain [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    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

  • post-hernioplasty chronic pain [ Time Frame: 1 months ] [ Designated as safety issue: No ]
    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

  • post-hernioplasty chronic pain [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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

  • post-hernioplasty chronic pain [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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

  • post-hernioplasty chronic pain [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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

  • post-hernioplasty chronic pain [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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

  • post-hernioplasty chronic pain [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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

  • post-hernioplasty chronic pain [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    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

  • post-hernioplasty chronic pain [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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

  • physical function [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    to measure the physical function score from the SF-36 questionnaire

  • physical function [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    to measure the physical function score from the SF-36 questionnaire

  • physical function [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    to measure the physical function score from the SF-36 questionnaire

  • physical function [ Time Frame: 1 months ] [ Designated as safety issue: No ]
    to measure the physical function score from the SF-36 questionnaire

  • physical function [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    to measure the physical function score from the SF-36 questionnaire

  • physical function [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    to measure the physical function score from the SF-36 questionnaire

  • physical function [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    to measure the physical function score from the SF-36 questionnaire

  • physical function [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    to measure the physical function score from the SF-36 questionnaire

  • physical function [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    to measure the physical function score from the SF-36 questionnaire

  • physical function [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    to measure the physical function score from the SF-36 questionnaire

  • physical function [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    to measure the physical function score from the SF-36 questionnaire

  • postoperative acute discomfort [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).

  • postoperative acute discomfort [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).

  • postoperative chronic discomfort [ Time Frame: 1 months ] [ Designated as safety issue: No ]
    to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).

  • postoperative chronic discomfort [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).

  • postoperative chronic discomfort [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).

  • postoperative chronic discomfort [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).

  • postoperative chronic discomfort [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).

  • postoperative chronic discomfort [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).

  • postoperative chronic discomfort [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).

  • postoperative chronic discomfort [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).

  • postoperative acute and chronic discomfort [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).

  • wound infection [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    to rate the wound infection risk.

  • wound infection [ Time Frame: 1 months ] [ Designated as safety issue: No ]
    to rate the wound infection risk.

  • wound infection [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    to rate the wound infection risk.

  • wound infection [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    to rate the wound infection risk.

  • wound infection [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    to rate the wound infection risk.

  • wound infection [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    to rate the wound infection risk.

  • wound infection [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    to rate the wound infection risk.

  • wound infection [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    to rate the wound infection risk.

  • wound infection [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    to rate the wound infection risk.

  • mesh shrinkage [ Time Frame: 1 months ] [ Designated as safety issue: No ]
    to measure the effectiveness shrinkage of the two different mesh using Ultrasound

  • mesh shrinkage [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    to measure the effectiveness shrinkage of the two different mesh using Ultrasound

  • mesh shrinkage [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    to measure the effectiveness shrinkage of the two different mesh using Ultrasound

  • mesh shrinkage [ Time Frame: 1 years ] [ Designated as safety issue: No ]
    to measure the effectiveness shrinkage of the two different mesh using Ultrasound

  • mesh shrinkage [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    to measure the effectiveness shrinkage of the two different mesh using Ultrasound

  • mesh shrinkage [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    to measure the effectiveness shrinkage of the two different mesh using Ultrasound

  • mesh shrinkage [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    to measure the effectiveness shrinkage of the two different mesh using Ultrasound

  • mesh shrinkage [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    to measure the effectiveness shrinkage of the two different mesh using Ultrasound


Estimated Enrollment: 70
Study Start Date: September 2009
Estimated Study Completion Date: September 2015
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01141335

Locations
Italy
UO Oneday-day Surgery, Azienda Ospedaliera Sant'Andrea
Rome, Italy, 00189
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
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
  More Information

No publications provided

Responsible Party: Francesco Saverio Mari, MD, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT01141335     History of Changes
Other Study ID Numbers: DS-002
Study First Received: June 9, 2010
Last Updated: February 3, 2012
Health Authority: Italy: II Faculty of Medicine and Surgery, University Sapienza of Rome

Keywords provided by University of Roma La Sapienza:
shrinkage
postoperative pain and discomfort

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Postoperative Complications
Recurrence
Wound Infection
Pathological Conditions, Anatomical
 Hernia, Abdominal
Pathologic Processes
Disease Attributes
Infection
Wounds and Injuries

ClinicalTrials.gov processed this record on May 16, 2013