The Desarda and Lichtenstein Techniques in Inguinal Hernia Treatment.

Study Overview
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Brief Summary
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Contemporary treatment of inguinal hernia is generally based on surgical methods with the use of synthetic meshes. The implanted meshes however have some disadvantages: they increase the risk of infection, tend to sustain inflammation process, can generate chronic pain and fertility disorders, can move from the initial implantation site, increase costs of treatment etc. The research to find any new hernioplasty without the use of meshes is still going on. Desarda in 2002 year published his own results over hernia treatment with the use of external oblique aponeurosis. These results were comparable with the effects of Lichtenstein technique. The initial assessment done in our own department revealed good clinical results after hernia treatment with Desarda's method. To make appropriate and objective clinical assessment of the Desarda's technique for primary inguinal hernia treatment the randomized multicentre double blinded clinical trial (RCT) was projected and conducted. Finally, 105 patients were included in the Desarda group and 103 in the Lichtenstein group. Personal clinical follow up was made up to 3 years after operation. Generally no statistically significant differences were found between these groups. The only difference was higher rate of seroma after Lichtenstein technique and different pain perception in both groups. To the summary it is clear that Desarda technique is quite attractive and good proposition for operative hernia treatment without mesh. The RCT was done with the use of SharePoint Portal Server (Microsoft) which seems to be appropriate for clinical trials.

Official Title
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The Desarda and Lichtenstein Techniques in Primary Hernia Treatment in Adult Males: Randomised, Multicenter, Blinded Study.

Conditions
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Hernia, Inguinal

Intervention / Treatment
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* Procedure: Desarda technique
* Procedure: Lichtenstein technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primary inguinal hernia male adults signed informed consent god condition of external oblique aponeurosis (assessed during the operation) Exclusion Criteria: age < 18 recurrent hernia incarcerated hernia diagnosed mental disorder manual reduction of hernia on inpatient infection at groin area wound or scar at the groin no consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Desarda group<br>Patients with primary inguinal hernia operated using the Desarda technique | Procedure: Desarda technique<br>* no mesh technique with undetached strip of external oblique aponeurosis placed at the floor of inguinal canal<br>|
| Experimental: Lichtenstein group<br>Patients with primary inguinal hernia operated using the Lichtenstein technique. | Procedure: Lichtenstein technique<br>* hernioplasty with the usage of plain polypropylene mesh<br>* Other names: open plain mesh technique;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence | hernia recurrence after surgical treatement | 3 years | 
| chronic pain | persistent chronic pain (lasting longer then 6 months) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surgical complications | edema, hematoma, ecchymosis, infaction of the wound | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inguinal hernia, hernia recurrence, no mesh techniques, Desarda technique