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To evaluate the safety and efficacy of the Lichtenstein's hernioplasty using the Surgisis ES soft tissue graft, as a mesh, and to compare it with the traditional Lichtenstein procedure performed with polypropylene mesh.
Inclusion and Exclusion Criteria
Inclusion criteria:
Exclusion criteria
Outcomes:
General objectives of the study will be:
The specific objectives of the study will be:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | The Lichtenstein tension-free hernioplasty with polypropylene mesh |
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| 2 | Experimental | The Surgisis mesh group: in this group of patients a 7x20cm Surgisis ES Soft Tissue Graft sheet will be used. In sterile manner the sheet will be removed from the peel-open package. The Surgisis sheet will be cut and fashioned as appropriate. Then the pre-shaped sheet will will be placed for at least 10 minutes into a sterile dish with sterile room-temperature normo-saline to be rehydrated. Using aseptic techique, the rehydrated Surgisis sheet will be transferred to the already prepared and dissected inguinal region and will be fixed with PDS II 2/0. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prolene Polypropylene Mesh | Device | The Lichtenstein tension-free hernioplasty consists of a swatch of polypropylene mesh, partway slit 1 cm from its inferior edge to accommodate the spermatic cord. The mesh is sutured circumferentially to the internal oblique abdominal muscle, the rectus sheath and the shelving edge of the inguinal ligament. The tails of the mesh are drawn around the cord and the inferior edge of each tail is sutured to the inguinal ligament. In case of direct hernias, no effort is made to repair the hernia itself. In indirect hernias the sac is excised, except for sliding hernias. The polypropylene mesh group: in this group of patients the polypropylene mesh will be fixed by the above mentioned sutures in Prolene 3/0. |
| Measure | Description | Time Frame |
|---|---|---|
| to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), simple verbal scale (SVS) and parenteral/oral analgesic consumption in the two groups | 1 week, 1, 3, 6 months, 1, 2, 3, 4, 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS) and simple verbal scale (SVS). | 3, 6 months, 1, 2, 3, 4, 5 years | |
| to rate the wound infection risk. | 1 week, 1, 3, 6 months, 1, 2, 3, 4, 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luca Ansaloni, MD | St.Orsola-malpighi Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St.Orsola-Malpighi University Hospital | Bologna | 40138 | Italy |
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| Surgisis Inguinal Hernia Matrix | Device | The Surgisis mesh group: in this group of patients a 7x20cm Surgisis ES Soft Tissue Graft sheet will be used. In sterile manner the sheet will be removed from the peel-open package. The Surgisis sheet will be cut and fashioned as appropriate. Then the pre-shaped sheet will will be placed for at least 10 minutes into a sterile dish with sterile room-temperature normo-saline to be rehydrated. Using aseptic techique, the rehydrated Surgisis sheet will be transferred to the already prepared and dissected inguinal region and will be fixed with PDS II 2/0. |
|
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| to monitor any other postoperative complication observed in the immediate, mid-term and long-term postoperative period. | 1 week, 1, 3, 6 months, 1, 2, 3, 4, 5 years |
| to measure the recurrence rate | 1 week, 1, 3, 6 months, 1, 2, 3, 4, 5 years |
| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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