Comparison of Inflammatory Stress Response Between Laparoscopic and Open Approach for Pediatric Inguinal Hernia Repair
| Registry | NCT03203343 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 32 (Actual) |
| Sponsor | University Hospital of Split (Other) |
| Conditions | Inguinal Hernia, Indirect, Children, Only, Inflammatory Response, Surgery, Interleukin-6, Tumor Necrosis Factor Alpha, C Reactive Protein, White Blood Cell Count, Leukocytes |
| Interventions | Operation - PIRS, Operation - MARCY (Procedure) |
| Dates | start 2017-05-01, primary completion 2018-06-01, completion 2018-06-25, first posted 2017-06-29, last updated 2018-12-19 |
| Locations | 1 site in Croatia |
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All trials for Inguinal Hernia, Indirect All trials for Children, Only All trials of Operation - PIRS All trials of Operation - MARCY
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| PIRS group | Active comparator | Procedure: Operation - PIRS | Patients operated laparoscopically - PIRS technique |
| Marcy group | Active comparator | Procedure: Operation - MARCY | Patients operated by open modified Marcy technique |
Sex: Male, ages: 3 Years to 7 Years, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| University hospital of Split | Split, Split-Dalmatia County | Croatia |