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To evaluate the efficacy of the use of swine dermal collagen prosthesis implanted preperitoneally as a prophylactic procedure against incisional hernia in patients operated in urgency/emergency setting in contaminated/infected fields with peritonitis. The aim of the study is to reduce the incidence of incisional hernia from 50% to 20%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm | Experimental | Patients randomized to this arm will be operated for the primary disease and at the end of the intervention the laparotomy will be closed reinforcing the suture with a swine dermis biological prosthesis positioned sublay |
|
| Control arm | Active Comparator | Patients randomized to this arm will be operated for the primary disease and at the end of the intervention the laparotomy will be closed by emi-continuous monofilament sutures with an intermediate-reabsorbable-time suture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biological swine dermis not cross-linked prosthesis positioning in incisional hernia prevention | Device | The mesh placement will be preceded by the plane preparation. The subcutaneous tissue will be dissociated from the anterior rectum-muscles fascia. The retro-muscular rectum muscles plane will be dissected preparing a 5-6 cm pouch necessary to the prosthesis positioning. The mesh will be fixed with at least 8 long-lasting absorbable transfix stitched. The prosthesis will be placed with at least a 5 cm overlap. If the peritoneal plane can be sutured a Jackson-Pratt 10 suction drain will be placed under the prosthesis. A Jackson-Pratt 10 suction drain will always be placed over the prosthesis. Anterior rectum fascia will be closed by emi-continuous monofilament suture with an intermediate-reabsorbable-time suture. Another Jackson-Pratt 10 suction drain will be placed over the anterior fascia if the subcutaneous tissue is thick. No subcutaneous suture will be performed. Skin stapler or interrupted stitches will be used to close the skin plane. |
| Measure | Description | Time Frame |
|---|---|---|
| Incisional hernia rate | 3 months | |
| Incisional hernia rate | 6 months | |
| Incisional hernia rate | 12 months | |
| Incisional hernia rate | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Morbidity | 0 months | |
| Morbidity | 3 months | |
| Morbidity |
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Inclusion Criteria:
• Patients aged > 18 years old
Exclusion Criteria:
• Patients aged < 18 years old
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Papa Giovanni XXIII hospital | Recruiting | Bergamo | 24128 | Italy |
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| ID | Term |
|---|---|
| D000069290 | Incisional Hernia |
| ID | Term |
|---|---|
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
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|
|
| Direct suture of the anterior abdominal wall fascia | Procedure | Anterior rectum fascia will be closed by emi-continuous monofilament suture with an intermediate-reabsorbable-time suture. No subcutaneous suture will be performed. Skin stapler or interrupted stitches will be used to close the skin plane. |
|
| 6 months |
| Morbidity | 12 months |
| Morbidity | 24 months |
| Length of surgery | Day 0 |
| Time to drain removal | participants will be followed for the duration of hospital stay, an expected average of 1-2 weeks |
| Length of stay in hospital | At the discharge, an expected average of 1-2 weeks after the intervention |
| Mortality | 0 months |
| Mortality | 3 months |
| Mortality | 6 months |
| Mortality | 12 months |
| Mortality | 24 months |
| D010335 | Pathologic Processes |