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This study aims to evaluate whether a surgical technique (Desarda) is superior to the commonly used surgical technique (Lichtenstein) in inguinal hernia repair concerning the occurrence of postoperative complications. The Lichtenstein technique involves the use of a mesh, while the Desarda technique does not.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Desarda Technique | Experimental | Patients asigned to this arm will be treated with Desarda Technique |
|
| Lichtenstein Technique | Active Comparator | Patients asigned to this arm will be treated with Lichtenstein Technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Desarda | Procedure | This technique prevent from using a mesh to surgical repair of a inguinal hernia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Participants with Post-surgery Complications | Any of the following complications: ● Sensation of a foreign body that persists beyond 3 months after surgery, self-reported by the participant ● Seroma within the first 30 days after surgery, verified through physical examination by a surgeon ● Hematoma within the first 30 days after surgery, verified through physical examination by a surgeon ● Infection at the surgical site within the first 30 days after surgery, verified by a surgeon ● Severe postoperative pain (7 or higher on the visual analog scale [VAS]) within the first 30 days after surgery, self-reported by the participant ● Chronic postoperative pain (persisting more than three months after surgery), self-reported by the participant ● Persistent loss of skin sensitivity beyond 30 days after surgery, self-reported by the participant ● Limitation of normal activities at home, outside the home, or at work beyond 3 months after surgery, self-reported by the participant | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
Patients with a weak, thin, or divided external oblique aponeurosis.
Participants diagnosed with any of the following conditions:
Women who have previously undergone a cesarean section
Cognitive or affective conditions that limit the ability to cooperate with the study procedures
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Javier Errando, MD | Contact | +34938960025 | jerrando@csapg.cat | |
| Noemi Casaponsa | Contact | +34 938960025 | 43197 | recerca@csapg.cat |
| Name | Affiliation | Role |
|---|---|---|
| Javier Errando, MD | CSAPG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CSAPG | Recruiting | Sant Pere de Ribes | Barcelona | 08810 | Spain |
IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research purposes and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).
After publication of main results of the study.
IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection. The requirements will be directed to the IP of the study. The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested. Next, the IP will transfer the request to the promotor center the study for the final decision.
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| 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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| Lichtenstein | Procedure | This technique implies using a mesh to surgical repair of a inguinal hernia |
|