Long-term Follow-up of Lichtenstein's Operation Versus Mesh Plug Repair

Study Overview
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Brief Summary
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Long-term follow-up of a randomized clinical trial of Lichtenstein's operation versus mesh plug for inguinal hernia repair based on the following published study Randomized clinical trial of Lichtenstein's operation versus mesh plug for inguinal hernia repair. Br J Surg. 2007 Jan;94(1):36-41. Primary endpoints is recurrence.

Official Title
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Long-term Follow-up of a Randomized Clinical Trial of Lichtenstein's Operation Versus Mesh Plug for Inguinal Hernia Repair

Conditions
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Inguinal Hernia

Intervention / Treatment
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* Procedure: Lichtenstein's operation
* Procedure: Mesh Plug Repair
* Drug: Opiate
* Drug: Paracetamol
* Drug: non-steroidal anti-inflammatory drug


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 40 years and older, patients who became 40 in the year of the operation were included (6 patients younger than 40 years were included because of explicit patient's wish). provision of written informed consent, symptomatic unilateral or bilateral inguinal hernia. Exclusion Criteria: presence of a femoral hernia, history of hernia repair with mesh, type I diabetes, presence of local or diffuse infection (urine, skin, lung, sepsis), immune deficiency, severe medical problems contraindicating safe induction of general anaesthesia or elective surgery, pregnancy, malignant tumours and life expectancy of less than 2 years

Ages Eligible for Study
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Minimum Age: 39 Years

Sexes Eligible for Study
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All

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Lichtenstein's Operation<br> | Procedure: Lichtenstein's operation<br> <br> Drug: Opiate<br>* Postoperative pain therapy<br>Drug: Paracetamol<br>* Postoperative pain therapy<br>Drug: non-steroidal anti-inflammatory drug<br>* Postoperative pain therapy<br>|
| Other: Mesh Plug Repair<br> | Procedure: Mesh Plug Repair<br> <br> Drug: Opiate<br>* Postoperative pain therapy<br>Drug: Paracetamol<br>* Postoperative pain therapy<br>Drug: non-steroidal anti-inflammatory drug<br>* Postoperative pain therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence | Recurrence after hernia operation (Lichtenstein's operatin versus mesh plug) | 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Pain measurement after inguinal hernia repair by visual analog scale (Lichtenstein's operatin versus mesh plug) | 6 years | 
| Reoperation | Reoperation after inguinal hernia repair (Lichtenstein's operatin versus mesh plug) | 6 years | 
| Sensitivity | Sensitivity after inguinal hernia repair (Lichtenstein's operatin versus mesh plug: 0 = normal, 1 = reduced, 2 = neuralgia | 6 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inguinal hernia repair, long-term follow-up, Surgical technique