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

Phase 4

Completed

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

• Registration Number: NCT01141335
• Lead Sponsor: University of Roma La Sapienza

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2010-06-09
• Study First Submitted QC: 2010-06-09
• Study First Posted: 2010-06-10
• Primary Completion: 2010-09
• Study Completion: 2015-09
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-20
• Last Update Posted: 2016-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
polypropylene mesh	polypropylene mesh	A Lichtenstein tension-free hernioplasty is performed using polypropylene mesh
PTFE mesh	Infinit® PTFE mesh (WL Gore)	A Lichtenstein tension-free hernioplasty is performed using PTFE mesh

Primary Outcome Measures

Name	Time	Method
post-hernioplasty acute pain	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

UO Oneday-day Surgery, Azienda Ospedaliera Sant'Andrea; 🇮🇹 Rome, Italy