Pain Clinical Trial
Official title:
Lichtenstein's Repair of Inguinal Hernia With Polypropylene Mesh Versus Infinit® PTFE Mesh, a Prospective Randomized, Double-blind, Controlled Trial
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.
Status | Completed |
Enrollment | 70 |
Est. completion date | September 2015 |
Est. primary completion date | September 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | UO Oneday-day Surgery, Azienda Ospedaliera Sant'Andrea | Rome |
Lead Sponsor | Collaborator |
---|---|
University of Roma La Sapienza |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | physical function | to measure the physical function score from the SF-36 questionnaire | 24 hours | No |
Secondary | postoperative acute discomfort | to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS). | 24 hours | No |
Secondary | wound infection | to rate the wound infection risk. | 7 days | No |
Secondary | postoperative complication | to monitor any other postoperative complication observed in the immediate, mid-term and long-term postoperative period. | from 24 hours to 5 years | No |
Secondary | recurrence | to measure the recurrence | from 1 months to 5 years | No |
Secondary | mesh shrinkage | to measure the effectiveness shrinkage of the two different mesh using Ultrasound | 14 days | No |
Secondary | 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 | 72 hours | No |
Secondary | 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 | 7 days | No |
Secondary | 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 | 14 days | No |
Secondary | 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 | 1 months | No |
Secondary | 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 | 3 months | No |
Secondary | 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 | 6 months | No |
Secondary | 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 | 1 year | No |
Secondary | 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 | 2 years | No |
Secondary | 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 | 3 years | No |
Secondary | 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 | 4 years | No |
Secondary | 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 | 5 years | No |
Secondary | physical function | to measure the physical function score from the SF-36 questionnaire | 72 hours | No |
Secondary | physical function | to measure the physical function score from the SF-36 questionnaire | 7 days | No |
Secondary | physical function | to measure the physical function score from the SF-36 questionnaire | 14 days | No |
Secondary | physical function | to measure the physical function score from the SF-36 questionnaire | 1 months | No |
Secondary | physical function | to measure the physical function score from the SF-36 questionnaire | 3 months | No |
Secondary | physical function | to measure the physical function score from the SF-36 questionnaire | 6 months | No |
Secondary | physical function | to measure the physical function score from the SF-36 questionnaire | 1 year | No |
Secondary | physical function | to measure the physical function score from the SF-36 questionnaire | 2 years | No |
Secondary | physical function | to measure the physical function score from the SF-36 questionnaire | 3 years | No |
Secondary | physical function | to measure the physical function score from the SF-36 questionnaire | 4 years | No |
Secondary | physical function | to measure the physical function score from the SF-36 questionnaire | 5 years | No |
Secondary | postoperative acute discomfort | to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS). | 72 hours | No |
Secondary | postoperative acute discomfort | to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS). | 14 days | No |
Secondary | postoperative chronic discomfort | to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS). | 1 months | No |
Secondary | postoperative chronic discomfort | to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS). | 3 months | No |
Secondary | postoperative chronic discomfort | to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS). | 6 months | No |
Secondary | postoperative chronic discomfort | to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS). | 1 year | No |
Secondary | postoperative chronic discomfort | to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS). | 2 years | No |
Secondary | postoperative chronic discomfort | to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS). | 3 years | No |
Secondary | postoperative chronic discomfort | to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS). | 4 years | No |
Secondary | postoperative chronic discomfort | to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS). | 5 years | No |
Secondary | postoperative acute and chronic discomfort | to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS). | 7 days | No |
Secondary | wound infection | to rate the wound infection risk. | 14 days | No |
Secondary | wound infection | to rate the wound infection risk. | 1 months | No |
Secondary | wound infection | to rate the wound infection risk. | 3 months | No |
Secondary | wound infection | to rate the wound infection risk. | 6 months | No |
Secondary | wound infection | to rate the wound infection risk. | 1 year | No |
Secondary | wound infection | to rate the wound infection risk. | 2 years | No |
Secondary | wound infection | to rate the wound infection risk. | 3 years | No |
Secondary | wound infection | to rate the wound infection risk. | 4 years | No |
Secondary | wound infection | to rate the wound infection risk. | 5 years | No |
Secondary | mesh shrinkage | to measure the effectiveness shrinkage of the two different mesh using Ultrasound | 1 months | No |
Secondary | mesh shrinkage | to measure the effectiveness shrinkage of the two different mesh using Ultrasound | 3 months | No |
Secondary | mesh shrinkage | to measure the effectiveness shrinkage of the two different mesh using Ultrasound | 6 months | No |
Secondary | mesh shrinkage | to measure the effectiveness shrinkage of the two different mesh using Ultrasound | 1 years | No |
Secondary | mesh shrinkage | to measure the effectiveness shrinkage of the two different mesh using Ultrasound | 2 years | No |
Secondary | mesh shrinkage | to measure the effectiveness shrinkage of the two different mesh using Ultrasound | 3 years | No |
Secondary | mesh shrinkage | to measure the effectiveness shrinkage of the two different mesh using Ultrasound | 4 years | No |
Secondary | mesh shrinkage | to measure the effectiveness shrinkage of the two different mesh using Ultrasound | 5 years | No |
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