About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult male patients aged 18 years or older.
Patients diagnosed with non-complicated inguinal hernia (both direct and indirect).
Patients able to provide written informed consent to participate in the study.
Disqualifiers
Patients younger than 18 years old.
Patients with complicated hernias (e.g., inflamed, obstructed, or strangulated hernias).
Patients with a recurrent inguinal hernia.
Patients with weak or thin external oblique aponeurosis (intraoperative findings).
Trial design
Parallel
Treatments tested in this trial
Lichtenstein Mesh-Based Hernioplasty
Procedure/SurgeryThis 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.
Combined Modified Guarnieri-Desarda Tissue-Based Hernioplasty
Procedure/SurgeryThis 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
Hernia Recurrence Rate
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.
Testicular Vascularity
Testicular vascularity will be evaluated using testicular duplex and ultrasound, comparing any changes pre- and post-surgery between the two groups.
Sponsors and contacts
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