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

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: Completed
• Conditions: Pain; Recurrence; Hernia; Wound Infection; Postoperative Complication; Physical Function
• Intervention / Treatment: Device: Infinit® PTFE mesh (WL Gore); Device: polypropylene mesh

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
post-hernioplasty acute pain	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

Outcome Measure	Measure Description	Time Frame
physical function	to measure the physical function score from the SF-36 questionnaire	24 hours
postoperative acute discomfort	to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).	24 hours
wound infection	to rate the wound infection risk.	7 days
postoperative complication	to monitor any other postoperative complication observed in the immediate, mid-term and long-term postoperative period.	from 24 hours to 5 years
recurrence	to measure the recurrence	from 1 months to 5 years
mesh shrinkage	to measure the effectiveness shrinkage of the two different mesh using Ultrasound	14 days
post-hernioplasty acute pain	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	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	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	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	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	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	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	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	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	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	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	to measure the physical function score from the SF-36 questionnaire	72 hours
physical function	to measure the physical function score from the SF-36 questionnaire	7 days
physical function	to measure the physical function score from the SF-36 questionnaire	14 days
physical function	to measure the physical function score from the SF-36 questionnaire	1 months
physical function	to measure the physical function score from the SF-36 questionnaire	3 months
physical function	to measure the physical function score from the SF-36 questionnaire	6 months
physical function	to measure the physical function score from the SF-36 questionnaire	1 year
physical function	to measure the physical function score from the SF-36 questionnaire	2 years
physical function	to measure the physical function score from the SF-36 questionnaire	3 years
physical function	to measure the physical function score from the SF-36 questionnaire	4 years
physical function	to measure the physical function score from the SF-36 questionnaire	5 years
postoperative acute discomfort	to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).	72 hours
postoperative acute discomfort	to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).	14 days
postoperative chronic discomfort	to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).	1 months
postoperative chronic discomfort	to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).	3 months
postoperative chronic discomfort	to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).	6 months
postoperative chronic discomfort	to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).	1 year
postoperative chronic discomfort	to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).	2 years
postoperative chronic discomfort	to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).	3 years
postoperative chronic discomfort	to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).	4 years
postoperative chronic discomfort	to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).	5 years
postoperative acute and chronic discomfort	to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).	7 days
wound infection	to rate the wound infection risk.	14 days
wound infection	to rate the wound infection risk.	1 months
wound infection	to rate the wound infection risk.	3 months
wound infection	to rate the wound infection risk.	6 months
wound infection	to rate the wound infection risk.	1 year
wound infection	to rate the wound infection risk.	2 years
wound infection	to rate the wound infection risk.	3 years
wound infection	to rate the wound infection risk.	4 years
wound infection	to rate the wound infection risk.	5 years
mesh shrinkage	to measure the effectiveness shrinkage of the two different mesh using Ultrasound	1 months
mesh shrinkage	to measure the effectiveness shrinkage of the two different mesh using Ultrasound	3 months
mesh shrinkage	to measure the effectiveness shrinkage of the two different mesh using Ultrasound	6 months
mesh shrinkage	to measure the effectiveness shrinkage of the two different mesh using Ultrasound	1 years
mesh shrinkage	to measure the effectiveness shrinkage of the two different mesh using Ultrasound	2 years
mesh shrinkage	to measure the effectiveness shrinkage of the two different mesh using Ultrasound	3 years
mesh shrinkage	to measure the effectiveness shrinkage of the two different mesh using Ultrasound	4 years
mesh shrinkage	to measure the effectiveness shrinkage of the two different mesh using Ultrasound	5 years

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: June 9, 2010
• First Submitted That Met QC Criteria: June 9, 2010
• First Posted (Estimate): June 10, 2010

Study Record Updates

• Last Update Posted (Estimate): November 22, 2016
• Last Update Submitted That Met QC Criteria: November 20, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: shrinkage; postoperative pain and discomfort
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Disease Attributes; Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal; Recurrence; Postoperative Complications; Wound Infection
• Other Study ID Numbers: DS-002