Rives Technique Versus Lichtenstein Repair for Primary Inguinal Hernia

Study Overview
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Brief Summary
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Lichtenstein technique, inserting a mesh over the inguinal cord in the neurological plane, is considered the standard of inguinal hernia repair, but it has 4% recurrence and 12% chronic postoperative pain. Rives technique inserts the mesh in the preperitoneal space behind the neurological plane and the muscular plane, thus better fulfilling the principle of hydrostatics.

Detailed Description
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These techniques have not been compared randomly for assessment of chronic pain, postoperative complications and recurrences

Official Title
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Randomized Clinical Trial of Rives Technique Versus Lichtenstein Repair for Primary Inguinal Hernia

Conditions
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Primary Inguinal Hernia

Intervention / Treatment
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* Procedure: Repair for primary inguinal hernia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women aged between 18 and 93 years (inclusive) at the time of the first screening visit. They must provide signed written informed consent and agree to comply the study protocol Exclusion Criteria: Refusal to give informed consent. Refusal to participate giant inguinal hernias

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 93 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: Single Group Assignment
Interventional Model Description: randomized,controlled and double-blind study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Rives technique<br>Rives technique for primary inguinal hernia | Procedure: Repair for primary inguinal hernia<br>* Repair for primary inguinal hernia<br>|
| Other: Lichtenstein repair<br>Lichtenstein repair for primary inguinal hernia | Procedure: Repair for primary inguinal hernia<br>* Repair for primary inguinal hernia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate postoperative complications of pain | The patients are clinically reviewed in the office within 7 days of discharge (pain is evaluated at rest and with movement (standing up, sitting down, and walking), using a VAS (visual analogue scale). Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the no pain anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in post- surgical patients, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm) | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the chronic pain | The patients are reviewed clinically by the service's surgeons again after a year. If pain is found, this is evaluated as being with movement, spontaneous, episodic, or constant in nature, and measured with a VAS. The patients are clinically reviewed in the office: pain is evaluated at rest and with movement (standing up, sitting down, and walking), using a VAS (visual analogue scale). Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the no pain anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in post- surgical patients, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm) | 1 year | 
| Evaluate the recurrences | The patients are reviewed clinically by the service's surgeons again after a year. The inguinal region is examined. A mass, reducible or otherwise, is regarded as a recurrence. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rives technique, Lichtenstein repair