NCT03203343

Inflammatory Stress Response in Pediatric Inguinal Hernia Repair

Comparison of Inflammatory Stress Response Between Laparoscopic and Open Approach for Pediatric Inguinal Hernia Repair

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: University Hospital of Split · Academic / Other
• Sex: Male
• Age: 3 Years – 7 Years
• Healthy volunteers: Accepted

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.

Conditions

• Inguinal Hernia, Indirect
• Children, Only
• Inflammatory Response
• Surgery
• Interleukin-6
• Tumor Necrosis Factor Alpha
• C Reactive Protein
• White Blood Cell Count, Leukocytes

Interventions

Type	Name	Description
PROCEDURE	Operation - PIRS	Operation by its known design for PIRS group
PROCEDURE	Operation - MARCY	Operation by its known design for MARCY group

Timeline

• Start date: 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 across 1 country: Croatia