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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PIRS group | Active Comparator | Patients operated laparoscopically - PIRS technique |
|
| Marcy group | Active Comparator | Patients operated by open modified Marcy technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Operation - PIRS | Procedure | Operation by its known design for PIRS group |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Male inguinal hernia
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University hospital of Split | Split | Split-Dalmatia County | 21000 | Croatia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30511312 | Derived | Jukic M, Pogorelic Z, Supe-Domic D, Jeroncic A. Comparison of inflammatory stress response between laparoscopic and open approach for pediatric inguinal hernia repair in children. Surg Endosc. 2019 Oct;33(10):3243-3250. doi: 10.1007/s00464-018-06611-y. Epub 2018 Dec 3. |
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Just investigators have insight in patient data, no such data (names and private data) would be written in the study for publishing
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| Operation - MARCY |
| Procedure |
Operation by its known design for MARCY group |
|
| 6 days after surgery |
| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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