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| Name | Class |
|---|---|
| Ana Sánchez Gollarte | UNKNOWN |
| Álvaro Robin Valle de Lersundi | UNKNOWN |
| Arturo Cruz Cidoncha | UNKNOWN |
| Almudena Moreno Elola-Olaso |
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Incisional hernia related to the umbilical trocar site is probably the most frequent complication after laparoscopic surgical procedures. However, this is an underestimated sequelae of laparoscopic surgery which may involve an important morbidity and an increase in healthcare costs.
The incidence of incisional trocar site hernia ranges from 20 to 35% of patients after laparoscopic surgery depending on the different investigations. Prophylactic meshes have been tried in an attempt to reduce the incidence of this complication in obese patients. In that sense, suture-meshes can be an alternative to conventional meshes to improve the incidence of incisional hernias.
INDURATE TRIAL aims to test if suture-mesh is capable of reducing the incidence of incisional hernia in patients with risk factors for the development of this frequent complication when compared with conventional monofilament sutures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group or Duramesh group | Experimental | Umbilical trocar closure using Suture-mesh (Duramesh suture). |
|
| Control group or poli(4)hidroxibutirate group | Active Comparator | Umbilical trocar closure using conventional monofilament suture. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| duramesh suture | Device | Duramesh-suture will be used for trocar closure in the experimental group |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of the umbilical trocar site hernia in each group | Evaluation of the incidence of umbilical trocar site hernia in duramesh group compared with the control group | 12 monts |
| Measure | Description | Time Frame |
|---|---|---|
| Infectious complications of the wound | Evaluation of the infectious complications related to umbilical wound after laparoscopic surgery. Compare the incidence of these complications in each group | 12 months |
| Seroma and hematoma |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miguel Ángel García Ureña | Recruiting | Madrid | 28022 | Spain |
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| ID | Term |
|---|---|
| D014946 | Wound Infection |
| ID | Term |
|---|---|
| D007239 | Infections |
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| UNKNOWN |
| Armando Galván Pérez | UNKNOWN |
| Ana María Minaya Bravo | UNKNOWN |
| Enrique González González | UNKNOWN |
| Carlos Guijarro Moreno | UNKNOWN |
| Asunción Aguilera Velardo | UNKNOWN |
| Patricia López Quindos | UNKNOWN |
| Clara María Martínez Moreno | UNKNOWN |
| Marina Pérez-Flecha González | UNKNOWN |
| Victor Vaello Jodra | UNKNOWN |
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Evaluation of the seroma and hematoma related to umbilical wound after laparoscopic surgery. Compare the incidence of these complications in each group
| 12 months |
| Intraabdominal events | Evaluation of intraabdominal events (fluid collections, bleeding, peritonitis...) and compare the incidence in each group. | 12 months |
| Skin dehiscence and/or necrosis | Evaluate the incidence of skin complications in each group. | 12 months |
| Early aponeurotic failure (evisceration) | Evaluation of early aponeurotic failure after laparoscopic procuderes and compare the incidence between the two different groups. | 12 months |