Inflammatory Stress Response in Pediatric Inguinal Hernia Repair

Study Overview
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Brief Summary
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Today there are various surgical techniques for inguinal hernia. In this study, investigators want to compare the ''PIRS'' operating technique laparoscopy and modified Marcy operating technique with open inguinal access. Investigators would compare both groups to find out witch one does the lesser inflammatory stress response on the organism.

Detailed Description
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Inguinal hernia represents the protrusion of the abdominal cavity contents through the inguinal canal. Today there are various surgical techniques for inguinal hernia. In this study, investigators want to compare two standard methods that are regularly performed at the University hospital of Split at department of pediatric surgery. These are the ''PIRS'' operating technique laparoscopy and modified Marcy operating technique with open inguinal access. The choice of operating technique depends solely on the choice of a chosen pediatric surgeon. Given the fact that the child is indicated for an operation, regardless of participation in the study, there are no significant risks of participating in this study, except for possible but rare complications resulting from the peripheral venous blood draw (haematoma, soreness and pain). To carry out this study, the child should be taken (drawn) 3 peripheral venous blood samples (on day of operation, 24 hours after surgery and 6 days after surgery) from which the laboratory parameters are taken and counted (Leukocytes, C - Reactive Protein, Interleukin 6 and Tumor necrosis factor α). Lab results would be compared between both groups to find out witch one does the lesser inflammatory stress response on the organism.

Official Title
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Comparison of Inflammatory Stress Response Between Laparoscopic and Open Approach for Pediatric Inguinal Hernia Repair

Conditions
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Inguinal Hernia, Indirect, Children, Only, Inflammatory Response, Surgery, Interleukin-6, Tumor Necrosis Factor Alpha, C Reactive Protein, White Blood Cell Count, Leukocytes

Intervention / Treatment
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* Procedure: Operation - PIRS
* Procedure: Operation - MARCY


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male children with inguinal hernia at age of 3 to 7 one-sided inguinal hernia Exclusion Criteria: Female children recurrent hernia bilateral hernia age less than 3 y, more than 7 y any general inflammatory process, illness intraoperative complications which may interfere with inflammatory stress response

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PIRS group<br>Patients operated laparoscopically - PIRS technique | Procedure: Operation - PIRS<br>* Operation by its known design for PIRS group<br>|
| Active Comparator: Marcy group<br>Patients operated by open modified Marcy technique | Procedure: Operation - MARCY<br>* Operation by its known design for MARCY group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in inflammatory stress response (IL6) | measurement of IL6 in pg/mL (according to manufacturer), change of the value in three time frames like mentioned below | 3 measurements: preoperative, 24 hours after and 6 days after surgery | 
| Change in inflammatory stress response (CRP) | measurement of C - reactive protein in mg/L, change of the value in three time frames like mentioned below | 3 measurements: preoperative, 24 hours after and 6 days after surgery | 
| Change in inflammatory stress response (TNF alpha) | measurement of Tumor necrosis factor alpha in pg/mL (according to manufacturer), change of the value in three time frames like mentioned below | 3 measurements: preoperative, 24 hours after and 6 days after surgery | 
| Change in inflammatory stress response (Leukocytes WBC) | measurement of white blood cell count in 10^9/L, change of the value in three time frames like mentioned below | 3 measurements: preoperative, 24 hours after and 6 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective pain assessment | Visual analog pain scale | 24 hours after and 6 days after surgery | 
| Subjective pain assessment | Visual analog pain scale | 6 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inguinal Hernia, Indirect, Children, Only, Inflammatory Response, Surgery, Interleukin-6, Tumor necrosis factor alpha, C reactive protein, Leukocytes