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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: May 21, 2013
Last verified: May 2013
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: May 21, 2013
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
Disease Attributes
Hernia, Abdominal
Infection
Pathologic Processes
Pathological Conditions, Anatomical
Wounds and Injuries

ClinicalTrials.gov processed this record on November 27, 2014