Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PTFE mesh | Experimental | A Lichtenstein tension-free hernioplasty is performed using PTFE mesh |
|
| polypropylene mesh | Active Comparator | A Lichtenstein tension-free hernioplasty is performed using polypropylene mesh |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| polypropylene mesh | Device | A Lichtenstein tension-free hernioplasty is performed using a polypropylene mesh will be fixed by sutures in Polypropylene 2/0. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| physical function | to measure the physical function score from the SF-36 questionnaire | 24 hours |
| postoperative acute discomfort | to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UO Oneday-day Surgery, Azienda Ospedaliera Sant'Andrea | Rome | Italy | 00189 | Italy |
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| D006547 | Hernia |
| D014946 | Wound Infection |
| D011183 | Postoperative Complications |
| D012008 | Recurrence |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020763 | Pathological Conditions, Anatomical |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
|
| 24 hours |
| wound infection | to rate the wound infection risk. | 7 days |
| 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 |
| recurrence | to measure the recurrence | from 1 months to 5 years |
| mesh shrinkage | to measure the effectiveness shrinkage of the two different mesh using Ultrasound | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 5 years |
| physical function | to measure the physical function score from the SF-36 questionnaire | 72 hours |
| physical function | to measure the physical function score from the SF-36 questionnaire | 7 days |
| physical function | to measure the physical function score from the SF-36 questionnaire | 14 days |
| physical function | to measure the physical function score from the SF-36 questionnaire | 1 months |
| physical function | to measure the physical function score from the SF-36 questionnaire | 3 months |
| physical function | to measure the physical function score from the SF-36 questionnaire | 6 months |
| physical function | to measure the physical function score from the SF-36 questionnaire | 1 year |
| physical function | to measure the physical function score from the SF-36 questionnaire | 2 years |
| physical function | to measure the physical function score from the SF-36 questionnaire | 3 years |
| physical function | to measure the physical function score from the SF-36 questionnaire | 4 years |
| physical function | to measure the physical function score from the SF-36 questionnaire | 5 years |
| postoperative acute discomfort | to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS). | 72 hours |
| postoperative acute discomfort | to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS). | 14 days |
| postoperative chronic discomfort | to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS). | 1 months |
| postoperative chronic discomfort | to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS). | 3 months |
| postoperative chronic discomfort | to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS). | 6 months |
| postoperative chronic discomfort | to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS). | 1 year |
| postoperative chronic discomfort | to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS). | 2 years |
| postoperative chronic discomfort | to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS). | 3 years |
| postoperative chronic discomfort | to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS). | 4 years |
| postoperative chronic discomfort | to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS). | 5 years |
| postoperative acute and chronic discomfort | to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS). | 7 days |
| wound infection | to rate the wound infection risk. | 14 days |
| wound infection | to rate the wound infection risk. | 1 months |
| wound infection | to rate the wound infection risk. | 3 months |
| wound infection | to rate the wound infection risk. | 6 months |
| wound infection | to rate the wound infection risk. | 1 year |
| wound infection | to rate the wound infection risk. | 2 years |
| wound infection | to rate the wound infection risk. | 3 years |
| wound infection | to rate the wound infection risk. | 4 years |
| wound infection | to rate the wound infection risk. | 5 years |
| mesh shrinkage | to measure the effectiveness shrinkage of the two different mesh using Ultrasound | 1 months |
| mesh shrinkage | to measure the effectiveness shrinkage of the two different mesh using Ultrasound | 3 months |
| mesh shrinkage | to measure the effectiveness shrinkage of the two different mesh using Ultrasound | 6 months |
| mesh shrinkage | to measure the effectiveness shrinkage of the two different mesh using Ultrasound | 1 years |
| mesh shrinkage | to measure the effectiveness shrinkage of the two different mesh using Ultrasound | 2 years |
| mesh shrinkage | to measure the effectiveness shrinkage of the two different mesh using Ultrasound | 3 years |
| mesh shrinkage | to measure the effectiveness shrinkage of the two different mesh using Ultrasound | 4 years |
| mesh shrinkage | to measure the effectiveness shrinkage of the two different mesh using Ultrasound | 5 years |
| D007239 | Infections |
| D010335 | Pathologic Processes |
| D020969 | Disease Attributes |