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The aim of this study is to compare the surgical outcome of both Lichnichtien tension free mesh hernioplasty of inguinal hernia and the combined modified Guarnieri Desarda technique in terms of postoperative pain, post operative complications (seroma, hematoma, wound infection), chronic inguinodenia, early recurrence and assessment of testicular vascularity and size by application of a testicular duplex and ultrasound.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lichtenstein Mesh-Based Repair | Active Comparator | Participants in this arm will undergo the Lichtenstein tension-free hernioplasty, which involves reinforcing the inguinal canal floor using a synthetic mesh. The mesh is fixed to the inguinal ligament and internal oblique aponeurosis, minimizing tension in the repair and reducing the risk of recurrence. |
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| Combined Modified Guarnieri-Desarda Tissue-Based Repair | Experimental | Participants in this arm will receive the combined modified Guarnieri-Desarda tissue-based repair. This approach involves reconstructing the inguinal canal without the use of synthetic mesh, using the patient's own tissues to reinforce the canal and reduce tension. The technique combines aspects of both the Guarnieri and Desarda methods, aiming to preserve the natural physiology of the inguinal canal while providing tension-free repair. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lichtenstein Mesh-Based Hernioplasty | Procedure | This is a tension-free hernioplasty procedure that uses a synthetic mesh to reinforce the inguinal canal floor. The mesh is fixed to the inguinal ligament and internal oblique aponeurosis, creating a barrier to prevent hernia recurrence. It is considered the gold standard for inguinal hernia repair and is widely used for its effectiveness in reducing recurrence rates and postoperative complications. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain Assessment | Postoperative pain will be evaluated using the Mankoski Pain Scale (0-10). Pain scores will be recorded at different time intervals to assess immediate and long-term postoperative pain, with scores from 0 to 2 considered negligible, and scores from 3 to 10 considered significant. | At 2 weeks, 1 month, 3 months, and 6 months post-surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Postoperative Complications | The occurrence of postoperative complications such as seroma, hematoma, wound infection, and testicular complications (e.g., hydrocele, cord induration) will be recorded and analyzed for each group. | At 2 weeks, 1 month, and 3 months post-surgery. |
| Hernia Recurrence Rate |
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Inclusion Criteria:
Exclusion Criteria:
Only individuals who self-identify as male are eligible to participate.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fadi F. Khalil, MSc | Contact | 01285612963 | +2 | fady.azmi37080@postgrad.kasralainy.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Fadi F. Khalil, MSc | Kasr El Aini Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kasralainy | Recruiting | Cairo | Egypt |
De-identified individual participant data (IPD) including demographic information, surgical outcomes, and follow-up data (postoperative pain scores, complications, testicular vascularity and size, and hernia recurrence rates) will be made available. Data will be shared with researchers upon reasonable request for the purpose of secondary analysis. Access to the data will be granted following the publication of the study results and will be available for up to 5 years after study completion. Participants' confidentiality will be protected, and any shared data will be anonymized.
Data will be available for a period of 5 years after the study is completed.
Who: Qualified researchers with a scientifically sound proposal will be able to access the individual participant data (IPD) and supporting information.
What: Researchers will be able to access de-identified IPD, including demographic data, surgical outcomes, follow-up data (e.g., pain scores, complications, testicular vascularity, and hernia recurrence), and supporting documents such as the study protocol, statistical analysis plan, and informed consent form.
How: Researchers must submit a formal request to the corresponding author detailing their research proposal, the objectives of the secondary analysis, and how the data will be used. Requests will be evaluated by the study investigators. If approved, data will be shared via a secure, password-protected data-sharing platform, ensuring compliance with data protection regulations.
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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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This study follows a parallel assignment model. Patients are randomly assigned to one of two groups: the Lichtenstein mesh-based repair group (L group) or the combined modified Guarnieri-Desarda tissue-based repair group (C group). The interventions are performed independently in each group, with outcomes compared between the two. There is no blinding in this study, and both the participants and the surgeons know which procedure is being performed (open-label study). The primary focus is on comparing the effectiveness and safety of the two surgical techniques.
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| Combined Modified Guarnieri-Desarda Tissue-Based Hernioplasty | Procedure | This technique combines elements of the Guarnieri and Desarda tissue-based repairs. It does not involve the use of synthetic mesh, relying instead on the patient's own tissues to reinforce the inguinal canal. The Guarnieri technique reshapes the internal ring to improve the inguinal canal's shutter mechanism, while the Desarda technique reinforces the posterior wall using the external oblique aponeurosis. This approach aims to preserve natural anatomy and minimize complications associated with mesh use. |
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The rate of hernia recurrence will be assessed through clinical examination and imaging, comparing recurrence between the Lichtenstein mesh-based repair group and the modified Guarnieri-Desarda tissue-based repair group. |
| At 6 months and 1 year post-surgery. |
| Testicular Vascularity | Testicular vascularity will be evaluated using testicular duplex and ultrasound, comparing any changes pre- and post-surgery between the two groups. | At 3 months post-surgery. |