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

University of Roma La Sapienza70 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Physical Function Pain Hernia Wound Infection Postoperative Complication Recurrence

Interventions

polypropylene meshDEVICE

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

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

UO Oneday-day Surgery, Azienda Ospedaliera Sant'Andrea

Rome, Italy, Italy

Outcomes

Primary Outcomes

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

Time frame: 24 hours

Secondary Outcomes

physical function

to measure the physical function score from the SF-36 questionnaire

Time frame: 24 hours

postoperative acute discomfort

to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).

Time frame: 24 hours

wound infection

to rate the wound infection risk.

Time frame: 7 days

postoperative complication

to monitor any other postoperative complication observed in the immediate, mid-term and long-term postoperative period.

Time frame: from 24 hours to 5 years

recurrence

to measure the recurrence

Time frame: from 1 months to 5 years

mesh shrinkage

to measure the effectiveness shrinkage of the two different mesh using Ultrasound

Time frame: 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

Data from ClinicalTrials.gov

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Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 5 years

physical function

to measure the physical function score from the SF-36 questionnaire

Time frame: 72 hours

physical function

to measure the physical function score from the SF-36 questionnaire

Time frame: 7 days

physical function

to measure the physical function score from the SF-36 questionnaire

Time frame: 14 days

physical function

to measure the physical function score from the SF-36 questionnaire

Time frame: 1 months

physical function

to measure the physical function score from the SF-36 questionnaire

Time frame: 3 months

physical function

to measure the physical function score from the SF-36 questionnaire

Time frame: 6 months

physical function

to measure the physical function score from the SF-36 questionnaire

Time frame: 1 year

physical function

to measure the physical function score from the SF-36 questionnaire

Time frame: 2 years

physical function

to measure the physical function score from the SF-36 questionnaire

Time frame: 3 years

physical function

to measure the physical function score from the SF-36 questionnaire

Time frame: 4 years

physical function

to measure the physical function score from the SF-36 questionnaire

Time frame: 5 years

postoperative acute discomfort

to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).

Time frame: 72 hours

postoperative acute discomfort

to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).

Time frame: 14 days

postoperative chronic discomfort

to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).

Time frame: 1 months

postoperative chronic discomfort

to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).

Time frame: 3 months

postoperative chronic discomfort

to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).

Time frame: 6 months

postoperative chronic discomfort

to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).

Time frame: 1 year

postoperative chronic discomfort

to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).

Time frame: 2 years

postoperative chronic discomfort

to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).

Time frame: 3 years

postoperative chronic discomfort

to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).

Time frame: 4 years

postoperative chronic discomfort

to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).

Time frame: 5 years

postoperative acute and chronic discomfort

to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS).

Time frame: 7 days

wound infection

to rate the wound infection risk.

Time frame: 14 days

wound infection

to rate the wound infection risk.

Time frame: 1 months

wound infection

to rate the wound infection risk.

Time frame: 3 months

wound infection

to rate the wound infection risk.

Time frame: 6 months

wound infection

to rate the wound infection risk.

Time frame: 1 year

wound infection

to rate the wound infection risk.

Time frame: 2 years

wound infection

to rate the wound infection risk.

Time frame: 3 years

wound infection

to rate the wound infection risk.

Time frame: 4 years

wound infection

to rate the wound infection risk.

Time frame: 5 years

mesh shrinkage

to measure the effectiveness shrinkage of the two different mesh using Ultrasound

Time frame: 1 months

mesh shrinkage

to measure the effectiveness shrinkage of the two different mesh using Ultrasound

Time frame: 3 months

mesh shrinkage

to measure the effectiveness shrinkage of the two different mesh using Ultrasound

Time frame: 6 months

mesh shrinkage

to measure the effectiveness shrinkage of the two different mesh using Ultrasound

Time frame: 1 years

mesh shrinkage

to measure the effectiveness shrinkage of the two different mesh using Ultrasound

Time frame: 2 years

mesh shrinkage

to measure the effectiveness shrinkage of the two different mesh using Ultrasound

Time frame: 3 years

mesh shrinkage

to measure the effectiveness shrinkage of the two different mesh using Ultrasound

Time frame: 4 years

mesh shrinkage

to measure the effectiveness shrinkage of the two different mesh using Ultrasound

Time frame: 5 years