Inflammatory Stress Response in Pediatric Inguinal Hernia Repair
- Conditions
- Children, OnlySurgeryInterleukin-6White Blood Cell Count, LeukocytesInguinal Hernia, IndirectInflammatory ResponseTumor Necrosis Factor AlphaC Reactive Protein
- Interventions
- Procedure: Operation - PIRSProcedure: Operation - MARCY
- Registration Number
- NCT03203343
- Lead Sponsor
- University Hospital of Split
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 32
- male children with inguinal hernia at age of 3 to 7
- one-sided inguinal hernia
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PIRS group Operation - PIRS Patients operated laparoscopically - PIRS technique Marcy group Operation - MARCY Patients operated by open modified Marcy technique
- Primary Outcome Measures
Name Time Method 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 (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 (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 Outcome Measures
Name Time Method Subjective pain assessment 6 days after surgery Visual analog pain scale
Trial Locations
- Locations (1)
University hospital of Split
🇭🇷Split, Splitsko Dalmatinska Županija, Croatia