Physical Function, Pain, Hernia, Wound Infection, Postoperative Complication, Recurrence
Conditions
Keywords
shrinkage, postoperative pain and discomfort
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.
Interventions
DEVICEpolypropylene mesh
A Lichtenstein tension-free hernioplasty is performed using a polypropylene mesh will be fixed by sutures in Polypropylene 2/0.
DEVICEInfinit® PTFE mesh (WL Gore)
A Lichtenstein tension-free hernioplasty is performed using a PTFE mesh will be fixed by sutures in PTFE 2/0.
Sponsors
University of Roma La Sapienza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| postoperative acute discomfort | 24 hours | to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS). |
| wound infection | 7 days | to rate the wound infection risk. |
| 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. |
| recurrence | from 1 months to 5 years | to measure the recurrence |
| physical function | 24 hours | to measure the physical function score from the SF-36 questionnaire |
| post-hernioplasty acute pain | 72 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 |
| post-hernioplasty chronic pain | 1 months | 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 chronic discomfort | 1 months | to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS). |
| postoperative acute and chronic discomfort | 7 days | to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS). |
| mesh shrinkage | 14 days | to measure the effectiveness shrinkage of the two different mesh using Ultrasound |
Countries
Italy
Outcome results
None listed