University hospital of Split
Split, Split-Dalmatia County, 21000, Croatia
NCT Number: NCT03203343
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.
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Notify Me3 year–7 year
Male
Interventional
Not applicable
Split, Split-Dalmatia County, 21000, Croatia
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Operation by its known design for PIRS group
Operation by its known design for MARCY group
Time frame: 3 measurements: preoperative, 24 hours after and 6 days after surgery
measurement of IL6 in pg/mL (according to manufacturer), change of the value in three time frames like mentioned below
Time frame: 3 measurements: preoperative, 24 hours after and 6 days after surgery
measurement of C - reactive protein in mg/L, change of the value in three time frames like mentioned below
Time frame: 3 measurements: preoperative, 24 hours after and 6 days after surgery
measurement of Tumor necrosis factor alpha in pg/mL (according to manufacturer), change of the value in three time frames like mentioned below
Time frame: 3 measurements: preoperative, 24 hours after and 6 days after surgery
measurement of white blood cell count in 10^9/L, change of the value in three time frames like mentioned below
Time frame: 24 hours after and 6 days after surgery
Visual analog pain scale
Time frame: 6 days after surgery
Visual analog pain scale
University Hospital of Split
Other
Comparison of Inflammatory Stress Response Between Laparoscopic and Open Approach for Pediatric Inguinal Hernia Repair
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