Clinical trial NCT01141335: Polypropylene Mesh Versus Polytetrafluoroethylene (PTFE) Mesh in Inguinal Hernia Repair
Official title: Lichtenstein's Repair of Inguinal Hernia With Polypropylene Mesh Versus Infinit® PTFE Mesh, a Prospective Randomized, Double-blind, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Physical Function
Pain
Hernia
Wound Infection
Postoperative Complication
Recurrence
Keywords: shrinkage
postoperative pain and discomfort
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2010-06-10
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: post-hernioplasty acute pain
timeFrame: 24 hours
Secondary outcomes:
measure: physical function
timeFrame: 24 hours
measure: postoperative acute discomfort
timeFrame: 24 hours
measure: wound infection
timeFrame: 7 days
measure: postoperative complication
timeFrame: from 24 hours to 5 years
measure: recurrence
timeFrame: from 1 months to 5 years
measure: mesh shrinkage
timeFrame: 14 days
measure: post-hernioplasty acute pain
timeFrame: 72 hours
measure: post-hernioplasty acute pain
timeFrame: 7 days
measure: post-hernioplasty acute pain
timeFrame: 14 days
measure: post-hernioplasty chronic pain
timeFrame: 1 months
measure: post-hernioplasty chronic pain
timeFrame: 3 months
measure: post-hernioplasty chronic pain
timeFrame: 6 months
measure: post-hernioplasty chronic pain
timeFrame: 1 year
measure: post-hernioplasty chronic pain
timeFrame: 2 years
measure: post-hernioplasty chronic pain
timeFrame: 3 years
measure: post-hernioplasty chronic pain
timeFrame: 4 years
measure: post-hernioplasty chronic pain
timeFrame: 5 years
measure: physical function
timeFrame: 72 hours
measure: physical function
timeFrame: 7 days
measure: physical function
timeFrame: 14 days
measure: physical function
timeFrame: 1 months
measure: physical function
timeFrame: 3 months
measure: physical function
timeFrame: 6 months
measure: physical function
timeFrame: 1 year
measure: physical function
timeFrame: 2 years
measure: physical function
timeFrame: 3 years
measure: physical function
timeFrame: 4 years
measure: physical function
timeFrame: 5 years
measure: postoperative acute discomfort
timeFrame: 72 hours
measure: postoperative acute discomfort
timeFrame: 14 days
measure: postoperative chronic discomfort
timeFrame: 1 months
measure: postoperative chronic discomfort
timeFrame: 3 months
measure: postoperative chronic discomfort
timeFrame: 6 months
measure: postoperative chronic discomfort
timeFrame: 1 year
measure: postoperative chronic discomfort
timeFrame: 2 years
measure: postoperative chronic discomfort
timeFrame: 3 years
measure: postoperative chronic discomfort
timeFrame: 4 years
measure: postoperative chronic discomfort
timeFrame: 5 years
measure: postoperative acute and chronic discomfort
timeFrame: 7 days
measure: wound infection
timeFrame: 14 days
measure: wound infection
timeFrame: 1 months
measure: wound infection
timeFrame: 3 months
measure: wound infection
timeFrame: 6 months
measure: wound infection
timeFrame: 1 year
measure: wound infection
timeFrame: 2 years
measure: wound infection
timeFrame: 3 years
measure: wound infection
timeFrame: 4 years
measure: wound infection
timeFrame: 5 years
measure: mesh shrinkage
timeFrame: 1 months
measure: mesh shrinkage
timeFrame: 3 months
measure: mesh shrinkage
timeFrame: 6 months
measure: mesh shrinkage
timeFrame: 1 years
measure: mesh shrinkage
timeFrame: 2 years
measure: mesh shrinkage
timeFrame: 3 years
measure: mesh shrinkage
timeFrame: 4 years
measure: mesh shrinkage
timeFrame: 5 years
Other outcomes:
Locations:
city: Rome
country: Italy
facility: UO Oneday-day Surgery, Azienda Ospedaliera Sant'Andrea
Study officials:
affiliation: Azienda Ospedaliera Sant'Andrea, Rome, Italy
name: Luigi Masoni, Dr.
role: STUDY_CHAIR
affiliation: Azienda Ospedaliera Sant'Andrea, Rome, Italy
name: Francesco Saverio Mari, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Azienda Ospedaliera Sant'Andrea, Rome, Italy
name: Antonio Brescia, Prof.
role: STUDY_DIRECTOR
affiliation: Azienda Ospedaliera Sant'Andrea, Rome, Italy
name: Giuseppe R Nigri, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Azienda Ospedaliera Sant'Andrea, Rome, Italy
name: Francesco Favi, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Azienda Ospedaliera Sant'Andrea, Rome, Italy
name: Andrea Milillo, Dr.
role: PRINCIPAL_INVESTIGATOR
References: