Children, Only, C Reactive Protein, Inflammatory Response, Inguinal Hernia, Indirect, Interleukin-6, Surgery, Tumor Necrosis Factor Alpha, White Blood Cell Count, Leukocytes
Conditions
Keywords
Inguinal Hernia, Indirect, Children, Only, Inflammatory Response, Surgery, Interleukin-6, Tumor necrosis factor alpha, C reactive protein, Leukocytes
Brief summary
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
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.
Interventions
PROCEDUREOperation - PIRS
Operation by its known design for PIRS group
PROCEDUREOperation - MARCY
Operation by its known design for MARCY group
Sponsors
University Hospital of Split
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
3 Years to 7 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in inflammatory stress response (IL6) | 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 |
| Change in inflammatory stress response (CRP) | 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 |
| Change in inflammatory stress response (TNF alpha) | 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 |
| Change in inflammatory stress response (Leukocytes WBC) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective pain assessment | 24 hours after and 6 days after surgery | Visual analog pain scale |
Countries
Croatia
Outcome results
None listed