Comparison Between Elliptical Domed Mesh Technique and Lichtenstein Technique in Inguinal Hernia

Study Overview
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Brief Summary
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The investigators describe a new surgical technique for inguinal hernia open repair, which will be compared with the Lichtenstein technique. The investigators seek to find the difference between the two techniques in postoperative pain.

Detailed Description
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The investigators randomly assigned 168 adult patients with uncomplicated primary inguinal hernia to two treatment groups: Group A: 84 patients treated with the new technique Group B: 84 patients treated with the technique of Lichtenstein (gold standard) The investigators reviewed the patients operated on one week, one month, three months and six months after surgery. The investigators evaluated the presence of moderate to severe pain in each technique, as well as the intensity of pain, measured by visual analogue scale. The investigators also determined the presence of inguinal dysesthesias in each technique, measured by dermatome mapping.

Official Title
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Comparison Between Elliptical Domed Mesh Technique and Lichtenstein Technique, to Reduce Postoperative Pain in Open Inguinal Hernia Repair

Conditions
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Inguinal Hernia

Intervention / Treatment
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* Procedure: Elliptical domed mesh technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients diagnosed with uncomplicated primary inguinal hernia mentally healthy patients patients without preoperative groin pain patients eligible for outpatient surgery Exclusion Criteria: patients with different surgical diagnosis

Ages Eligible for Study
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Minimum Age: 18 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Elliptical domed mesh technique<br>84 adult patients with primary uncomplicated inguinal hernia, treated with an open preperitoneal elliptical mesh technique | Procedure: Elliptical domed mesh technique<br>* A segment of polypropylene mesh of 10 by 15cm enters the inguinal preperitoneal space, where takes the form of a dome and is fixed by four stitches<br>* Other names: preperitoneal mesh;|
| Active Comparator: Lichtenstein technique<br>84 adult patients with primary uncomplicated inguinal hernia treated with the Lichtenstein technique (gold standard) | Procedure: Elliptical domed mesh technique<br>* A segment of polypropylene mesh of 10 by 15cm enters the inguinal preperitoneal space, where takes the form of a dome and is fixed by four stitches<br>* Other names: preperitoneal mesh;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain one month after surgery | Pain will be measured by the Visual Analogue Scale, from zero to ten. Measurements will be made per month, three months and six months after surgery. With these data we will built two survival curves (one for each group)with the proportions of patients still have pain in every time frame. We will compare the two curves with logrank statistic test. | one month | 
| pain three months after surgery | Pain will be measured by the Visual Analogue Scale, from zero to ten. Measurements will be made per month, three months and six months after surgery. With these data we will built two survival curves (one for each group)with the proportions of patients still have pain in every time frame. We will compare the two curves with logrank statistic test. | three months | 
| pain six months after surgery | Pain will be measured by the Visual Analogue Scale, from zero to ten. Measurements will be made per month, three months and six months after surgery. With these data we will built two survival curves (one for each group)with the proportions of patients still have pain in every time frame. We will compare the two curves with logrank statistic test. | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dysesthesia one month after surgery | Inguinal dysesthesia will be measured by inguinal dermatome mapping, looking for anesthesia, hypoesthesia and hyperesthesia. Dysesthesias will be measured at one month, three months and six months. We dont know if there will be changes in dysesthesias over time but it is possible. | one month | 
| dysesthesia three months after surgery | Inguinal dysesthesia will be measured by inguinal dermatome mapping, looking for anesthesia, hypoesthesia and hyperesthesia. Dysesthesias will be measured at one month, three months and six months. We dont know if there will be changes in dysesthesias over time but it is possible. | three months | 
| dysesthesia six months after surgery | Inguinal dysesthesia will be measured by inguinal dermatome mapping, looking for anesthesia, hypoesthesia and hyperesthesia. Dysesthesias will be measured at one month, three months and six months. We dont know if there will be changes in dysesthesias over time but it is possible. | six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mesh, inguinal, hernia, pain, inguinodynia