NCT01141335

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2009

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 10, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

November 22, 2016

Status Verified

November 1, 2016

Enrollment Period

1 year

First QC Date

June 9, 2010

Last Update Submit

November 20, 2016

Conditions

Physical FunctionPainHerniaWound InfectionPostoperative ComplicationRecurrence

Keywords

shrinkagepostoperative pain and discomfort

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (56)

  • physical function

    24 hours

  • postoperative acute discomfort

    24 hours

  • wound infection

    7 days

  • postoperative complication

    from 24 hours to 5 years

  • recurrence

    from 1 months to 5 years

  • +51 more secondary outcomes

Study Arms (2)

PTFE mesh

EXPERIMENTAL

A Lichtenstein tension-free hernioplasty is performed using PTFE mesh

Device: Infinit® PTFE mesh (WL Gore)

polypropylene mesh

ACTIVE COMPARATOR

A Lichtenstein tension-free hernioplasty is performed using polypropylene mesh

Device: polypropylene mesh

Interventions

polypropylene meshDEVICE

A Lichtenstein tension-free hernioplasty is performed using a polypropylene mesh will be fixed by sutures in Polypropylene 2/0.

polypropylene mesh
Infinit® PTFE mesh (WL Gore)DEVICE

A Lichtenstein tension-free hernioplasty is performed using a PTFE mesh will be fixed by sutures in PTFE 2/0.

PTFE mesh

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UO Oneday-day Surgery, Azienda Ospedaliera Sant'Andrea

Rome, Italy, 00189, Italy

Location

MeSH Terms

Conditions

PainHerniaWound InfectionPostoperative ComplicationsRecurrencePain, Postoperative

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPathological Conditions, AnatomicalInfectionsPathologic ProcessesDisease Attributes

Study Officials

  • Luigi Masoni, Dr.

    Azienda Ospedaliera Sant'Andrea, Rome, Italy

    STUDY CHAIR

  • Francesco Saverio Mari, Dr.

    Azienda Ospedaliera Sant'Andrea, Rome, Italy

    PRINCIPAL INVESTIGATOR

  • Antonio Brescia, Prof.

    Azienda Ospedaliera Sant'Andrea, Rome, Italy

    STUDY DIRECTOR

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 9, 2010

First Posted

June 10, 2010

Study Start

September 1, 2009

Primary Completion

September 1, 2010

Study Completion

September 1, 2015

Last Updated

November 22, 2016

Record last verified: 2016-11

Locations

IT(1)